A Dissertation on EVALUATION of EFFECTIVENESS of HOT MUSTARD PACK with FOMENTATION on PATIENTS with LUMBAR SPONDYLOSIS Submitted

A Dissertation On

EVALUATION OF EFFECTIVENESS OF HOT MUSTARD PACK WITH

FOMENTATION ON PATIENTS WITH LUMBAR SPONDYLOSIS

Submitted by

Dr. C. SENTHILKUMAR, B.N.Y.S (Reg. No. 461511005)

Under the guidance of Prof. Dr. N. MANAVALAN, N.D. (OSM), M.A (G.T), M.Sc (Y&N), M.Phil, P.G.D.Y, P.G.D.H.M, P.G.D.H.H

Submitted to

The Tamil Nadu Dr.M.G.R.Medical University, Chennai

In partial fulfillment of the requirements for the award of degree of

DOCTOR OF MEDICINE BRANCH – I: NATUROPATHY

POST GRADUATE DEPARTMENT OF NATUROPATHY

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE AND HOSPITAL, CHENNAI – 600 106. OCTOBER 2018 GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU

CERTIFICATE BY THE GUIDE

This is to certify that “EVALUATION OF EFFECTIVENESS OF HOT

MUSTARD PACK WITH FOMENTATION ON PATIENTS WITH

LUMBAR SPONDYLOSIS” is a bonafied work done by the Post graduate

Dr.C.SENTHILKUMAR, Department of Naturopathy, Government Yoga and

Naturopathy Medical College and Hospital, Chennai-600106, under my guidance and supervision in partial fulfillment of regulations of

The Tamilnadu Dr.M.G.R.Medical University, Chennai for the award of degree of DOCTOR OF MEDICINE (M.D) – Naturopathy, BRANCH – I during the academic period October 2015 to 2018.

Place: Chennai. SIGNATURE OF THE GUIDE

Date:

Dr.N.MANAVALAN, N.D (OSM),M.Phil, M.A(G.T); M.Sc (Y&N),P.G.D.Y; P.G.D.H.M; P.G.D.H.H, Head of the Department - Department of Naturopathy, Government Yoga and Naturopathy Medical College and Hospital, Chennai – 106.

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU

ENDORSEMENT BY THE HEAD OF THE DEPARTMENT

I certify that the dissertation entitled “EVALUATION OF

EFFECTIVENESS OF HOT MUSTARD PACK WITH FOMENTATION

ON PATIENTS WITH LUMBAR SPONDYLOSIS” is the record of original research work carried out by Dr.C.SENTHIL KUMAR, Department of Naturopathy, Government Yoga and Naturopathy Medical College and

Hospital, Chennai – 600 106, submitted for the degree of DOCTOR OF

MEDICINE M.D – Branch – I (Naturopathy) under my guidance and supervision, and that this work has not formed the basis for the award of any degree, diploma, associate ship, fellowship or other titles in this University or any other University or Institution of higher learning.

Place: Chennai. SIGNATURE OF THE H.O.D

Date: Dr.N.MANAVALAN, N.D (OSM),M.Phil, M.A(G.T); M.Sc (Y&N),P.G.D.Y; P.G.D.H.M; P.G.D.H.H, Head of the Department - Department of Naturopathy, Government Yoga and Naturopathy Medical College and Hospital, Chennai – 106.

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU

ENDORSEMENT BY THE PRINCIPAL

I certify that the dissertation entitled “EVALUATION OF

EFFECTIVENESS OF HOT MUSTARD PACK WITH FOMENTATION

ON PATIENTS WITH LUMBAR SPONDYLOSIS” is the record of original research work carried out by Dr.C.SENTHILKUMAR, Department of Naturopathy, Government Yoga and Naturopathy Medical College and

Hospital, Chennai – 600 106 submitted for the award of degree of DOCTOR

OF MEDICINE (M.D) Branch – I (Naturopathy) under my guidance and supervision, and that this work has not formed the basis for the award of any degree, diploma, associate ship, fellowship or other titles in this University or any other University or Institution of higher learning.

Place: Chennai. SIGNATURE OF THE PRINCIPAL

iii

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU.

DECLARATION BY THE CANDIDATE

I, Dr.C.SENTHILKUMAR, solemnly declare that this dissertation entitled

“EVALUATION OF EFFECTIVENESS OF HOT MUSTARD PACK

WITH FOMENTATION ON PATIENTS WITH LUMBAR

SPONDYLOSIS” is a bonafied and genuine research work carried out by me at Government Yoga and Naturopathy Medical College and Hospital, Chennai from October 2015 - October 2018 under the guidance and supervision of Dr.N.MANAVALAN, N.D(OSM), M.Phil, M.A(G.T);M.Sc

(Y&N),P.G.D.Y; P.G.D.H.M; P.G.D.H.H, Head of the Department -

Department of Naturopathy. This dissertation is submitted to The Tamilnadu

Dr.M.G.R.Medical University, Chennai towards partial fulfillment of requirements for the award of M.D. Degree (Branch – I –Naturopathy) in

Yoga and Naturopathy.

Place: Chennai Signature of the candidate

Date: (Dr. C. SENTHILKUMAR)

iv INSTITUTIONAL ETHICAL COMMITTEE

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI – 600 106.

CERTIFICATE OF APPROVAL

The Institutional Ethical Committee of Government Yoga & Naturopathy

Medical College and Hospital, Chennai reviewed and discussed the application for approval of “EVALUATION OF EFFECTIVENESS OF HOT

MUSTARD PACK WITH FOMENTATION ON PATIENTS WITH

LUMBAR SPONDYLOSIS, project work submitted by

Dr.C.SENTHILKUMAR, 2nd year M.D. Naturopathy, Post graduate,

Government Yoga and Naturopathy Medical College and Hospital, Chennai.

The proposal is APPROVED.

The Institutional Ethical Committee expects to be informed about the progress of the study and adverse drug reactions during the course of the study and any change in the protocol and patient information sheet / informed consent and asks to be provided a copy of the final report.

DECLARATION BY THE CANDIDATE

I hereby declare that the Tamilnadu Dr.M.G.R.Medical University, Chennai,

Tamilnadu shall have the rights to preserve, use and disseminate this

Dissertation / Thesis in print or electronic format for academic / research purpose.

Place: Chennai Signature of the candidate,

Date: (Dr.C.SENTHILKUMAR)

ACKNOWLEDGEMENT

First of all I thank the Almighty God for giving me perception and strength to complete this study successfully.

The writing of this dissertation has been one of the most significant academic experiences I have ever had to face. Without the support, endurance and guidance of the following people, this study would not have been completed.

I am thankful for their aspirant guidance, invaluably productive criticism and welcoming advice during the project work. I am sincerely grateful to them for sharing their ingenuous and illuminating views on a number of issues related to the project. It is to them that I owe my deepest gratitude.

I am sincerely thankful and grateful to our beloved principal and The Head

Of The Department, Department Of Naturopathy, Dr. N.MANAVALAN, N.D

(osm), M.Phil., M.A (G.T); M.Sc (Y&N),PGDYP; P.G.D.H.M; P.G.D.H.H. for the guidance, acceptance and approval of this study.

I take this opportunity to express my heart felt gratitude to my HOD, and also extend my gratitude towards Dr.S.T. Venkateswaran, HOD, Division of Yoga

& Physical Therapeutics, Dr.R.S. Himeshwari H.O.D. Acupuncture and Energy

Medicine GYNMC, Arumbakkam, Chennai-106, for their relentless support and encouragement.

My special thanks to all the faculties for their constant support, sustenance, assistance and suggestions throughout this study.

vii

My sincere thanks to Dr. Chandrasekar for completing all the statistical data analysis required for this study.

My heartfelt thanks to all the non-teaching staffs of GYNMC and especially the therapist for helping me in conducting the treatment.

I thank all my friends and colleagues of GYNMC for their timely help and assisting me in completing the study

I would like to thank the participants who accepted, regularly attended and co – operated in this study.

Words won’t be enough to express the moral support that I received from my family members, especially parents & my spouse Mrs. M. Gomathi M. Pharm

(Pharmaceutics) whose genuine love and affection made me overcome some very bad phases of life.

Date: (Dr. C. SENTHILKUMAR)

viii

LIST OF ABBREVIATIONS USED

DD Disc degeneration

LS Lumbar spondylosis

CT scan Computed Tomography

MRI Magnetic Resonance Imaging

NSAID’s Non-steroidal anti-inflammatory drugs

LBP Low Back Pain

CLBP Chronic Low Back Pain

HMPF Hot Mustard Pack with Fomentation

IVDP Intervertebral Disc prolapse

VAS Visual Analogue Scale

RODI Revised Oswestry Disability Index

NTT Neural Tension Tests

ROM Range of Motion

SLR Straight Leg Raising

SPSS Statistical Package for the Social Sciences

ABSTRACT

Objective: To evaluate the effectiveness of Hot Mustard Pack with

Fomentation (HMPF) on Low Back Pain (LBP) in patients with Lumbar

Spondylosis.

Background: Lumbar spondylosis can be described as all degenerative conditions affecting the disks, vertebral bodies, and associated joints of the lumbar vertebrae and neurologic claudication, which includes: lower back pain, leg pain, numbness when standing and walking. Previous literatures have reported that mustard plasters are very effective in the reduction of pain among patients with various types of arthritis, knee pain, aching backs, etc. Present study envisioned towards evaluating the effect of HMPF on

LBP.

Design: Pre and post Experimental study

Study Setting: Outpatients of Government Yoga and Naturopathy Medical

College and Hospital (GYNMCH), Arumbakkam, Chennai.

Method: The study included 30 subjects with lumbar spondylosis. The patients were randomly selected from the outpatient department of

GYNMCH. The subjects abiding the inclusion and exclusion criteria were recruited to study the effect of hot mustard pack with fomentation. The pre-test and post-test data from the patients were collected and assessed with Visual Analogue Scale (VAS), Revised Oswestry Disability Index

(RODI) and additionally with Neural Tension Test (NTT) and Range Of

Motion (ROM).

RESULT: The study showed significant detraction in the pain and inability variables of the study participants. The post intervention data showed significant reduction of pain, disability, NTT, and ROM comparatively to that of the pre intervention data.

CONCLUSION: The study concluded that the effect of Hot Mustard Pack with Fomentation was very effective in reducing the severity of low back pain and disability in patients with lumbar spondylosis.

Keywords: lumbar spondylosis, hot mustard pack with fomentation, low back pain, VAS, RODI.

Table of contents

Sl. No. INDEX Page No.

1 INTRODUCTION 1

2 AIM AND OBJECTIVES 20

3 REVIEW OF LITERATURE 21

4 NEED FOR THE STUDY 41

5 METHODOLOGY 43

6 RESULTS 59

7 DISCUSSION 75

8 CONCLUSION 79

9 LIMITATIONS 80

10 REFERENCES 81

11 ANNEXURE 95

xii

LIST OF TABLES

Table No. Topic Page No. 1 Mean, Variance, Median and Standard 61 Deviation For Pain and Inability 2 Disability based on MODI score and analysed 63 using chi-square test 3 Mean, Variance, Median and Standard 65

Deviation of Lumbar Flexion and Extension

4 Straight Leg Raising Variable Pre and Post 67

Treatment

5 Bowstring sign Variable Pre and Post 69

Treatment.

6 Bowstring sign (%) calculated using Chi-Square 71

test

7 Comparison of Effect of Pain, Disability, 73

NTT and ROM Variables Pre and Post

Treatment

xiii

LIST OF FIGURES AND GRAPHS

Fig No. CONTENTS Page No. Normal spine and degenerative conditions 1 2 Normal and osteoarthritic spine 2 5 Features of Lumbar Spondylosis spine 3 7 Illustration of Data Points 4 47 The trial Profile of the study illustrating the study plan 5 48 Visual Analogue Scale 6 50

Graph CONTENTS Page No. No. 1 VAS and RODI variable pre and post treatment 62

2 Disability based MODI score – analysed using chi- 64 square test 3 Lumbar Flexion and Extension variable pre and post 66 treatment 4 Straight Leg Raising Variable Pre and Post Treatment 68

5 Bowstring sign Variable pre and post treatment 70

6 Bowstring sign (%) calculated using Chi-square test 72

7 Pain, disability, NTT and ROM parameters before 74 and after treatment

xiv

1.0 INTRODUCTION

Like a modern skyscraper, the human spine defies gravity, and defines us as vertical bipeds. It forms the infrastructure of a biological machine that anchors the kinetic chain and transfers biomechanical forces into coordinated functional activities. The spine acts as a conduit for precious neural structures and possesses the physiological capacity to act as a crane for lifting and a crankshaft for walking.

Subjected to aging, the spine adjusts to the wear and tear of gravity and biomechanical loading through compensatory structural and neurochemical changes, some of which can be maladaptive and cause pain, functional disability, and altered neurophysiologic circuitry. Some compensatory reactions are benign; however, some are destructive and interfere with the organism’s capacity to function and cope.

Spinal pain is multifaceted, involving structural, biomechanical, biochemical, medical, and psychosocial influences that result in dilemmas of such complexity that treatment is often difficult or ineffective. The origin of chronic back pain is often assumed to be degenerative conditions of the spine; degenerative changes and injury to spinal structures produce lower back and leg pain that vary proportionally (1). The spine representing the normal condition and the degenerative changes are shown in Fig 1.

Figure 1 - Normal spine and degenerative conditions

The terms lumbar osteoarthritis, disk degeneration, degenerative disk disease, and spondylosis are used to describe anatomical changes to the vertebral bodies and intervertebral disk spaces that may be associated with clinical pain syndromes.(2) Intervertebral disc degeneration (DD) is thought to be the first step in degenerative spinal changes, and is typically followed by the gradual formation of osteophytes, disc narrowing, and spinal stenosis.(3)

Degenerative disease of the spine is an inevitable consequence of ageing. Back pain is a frequent complaint, but in general practice it has been reported that a definite cause for the pain is established in only about 15% of patients.

Degenerative changes in the vertebrae, intervertebral discs and ligaments become increasingly common with age (4).

1.1 PHYSIOPATHOLOGY OF DISC DEGENERATION

1.1.1 Disc degeneration conditioning factors

There are many factors that lead to the degeneration of the intervertebral disc; they can be grouped into the following categories: age, genetic factors and environmental factors.

Age

The degenerative phenomena of the spine are part of the normal ageing process. Degeneration begins in the second decade of a man’s life and in the third decade in the case of women. At the age of forty, 80% of the discs in men and 65% in women are degenerated.

Genetic factors

These factors have been proven in studies on twins, as well as in studies of the relatives of patients treated for lumbar disc herniation.

Environmental factors

The percentages for disc degeneration observed through magnetic resonance imaging are notably higher in smokers than in non-smokers. Tobacco reduces the vascular supply of the disc through the endplates, causing hypoxia and degeneration, as well as a reduction in the production of type II collagen in the nucleus. (5)

1.2 SPONDYLOSIS

The word spondylosis comes from the Greek word for vertebrae.

Spondylosis refers to degenerative changes in the spine such as bone spurs and degenerating intervertebral discs between the vertebrae.

Spondylosis changes in the spine are frequently referred to as osteoarthritis. For example, the phrase "spondylosis of the lumbar spine" means degenerative changes such as osteoarthritis of the vertebral joints and degenerating intervertebral discs (degenerative disc disease) in the low back as shown in

Fig 2.

Figure 2 - Normal and osteoarthritic spine

Spondylosis can occur in the cervical spine (neck), thoracic spine (upper and mid back), or lumbar spine (low back). Lumbar spondylosis and cervical spondylosis are the most common.

Thoracic spondylosis frequently does not cause symptoms.

Lumbosacral spondylosis is spondylosis that affects both the lumbar spine and the sacral spine (below the lumbar spine, in the midline between the buttocks). Multilevel spondylosis means that these changes affect multiple vertebrae in the spine.

1.3 LUMBAR SPONDYLOSIS

Lumbar spondylosis is a degenerative condition that develops gradually over time, being more common in older individuals. This condition can also be referred to as spinal osteoarthritis. It occurs due to the wear-and-tear of the bones that happens from normal everyday movement. The lower spine is composed of disc-like structures that are cushioned by soft gel-like sections in between them. The purpose of these sections is to promote flexibility and absorb the load of stress applied to the vertebra. (6)

Degeneration of these areas causes a loss of elasticity and a propensity to be torn or damaged. If this type of damage were to occur, it may lead to a condition called disc prolapse, disc herniation, or a slipped disc, a common feature of lumbar spondylosis as in Figure 3.

Figure 3 - Features of lumbar spondylosis spine

1.3.1 CAUSES AND RISK FACTORS OF LUMBAR SPONDYLOSIS

Aging: The most common cause as the passage of time can lead to changes in the bones of the spine and other problems. Unfortunately, this often means that the disease is progressive and irreversible. Being over the age of 40 increases one’s risk for lumbar spondylosis.

Abnormal spinal movement: Frequent overuse of the back as seen during sports or other physically strenuous activity can put increased amounts of stress on the lumbar vertebrae, leading to injury.

Generics: Those genetically predisposed to weak bones and ligaments may be at increased risk for injury to the lumbar spine.

Lifestyle: Certain lifestyle habits affect the integrity of bones. Smoking, for example, decreases the amount of water in your discs, which are needed to absorb impact.

Obesity: Excess weight put extra load on the joints of the lumbar region, accelerating wear-and-tear of the lumbar joints.

Prolonged sitting: Puts pressure on the lumbar vertebrae.

Prior injury: Makes one more susceptible for lumbar spondylosis development.

1.3.2 LUMBAR SPONDYLOSIS SYMPTOMS

While just thinking of injuring the bones in the lower back can induce wincing, 37 percent of patients suffering from lumbar spondylosis do not have symptoms initially. But when symptoms do appear, they can present as pain ranging from mild to severe, initially presenting as stiffness in the mornings lasting for more than 30 minutes. Additions symptoms of lumbar spondylosis include:

• Localized pain

• Pain after prolonged sitting

• Worsening pain after repeated movement

• Muscle spasms

• Regional tenderness

• Tingling, numbness in the limbs

• Weakness of affected limb due to possible nerve compression

1.3.3 DIAGNOSING LUMBAR SPONDYLOSIS

This initial assessment will need to be complemented by more definitive diagnostic testing like,

X-Ray: Can show bone spurs on the vertebral bodies of the spine, thickening of the facet joints, and narrowing of the intervertebral disc spaces.

CT scan: Provides greater image detail and can diagnose narrowing of the spinal canal if present.

MRI: Shows the most detail of any of the previous tests mentioned, but is also the most expensive. It is ideal for visualizing the intervertebral discs, including the degree of disc herniation if present.

SPECT: Single-photon emission computed tomography bone scintigraphy can be used to further evaluate patients with suspected spondylolysis. (7)

1.3.4 TREATING LUMBAR SPONDYLOSIS

Having chronic lower back pain can cause a lot of difficulty standing or even sitting, so many treatment options focus on relieving this aspect of lumbar spondylosis. In the case of severe disc prolapse, surgery may be required.

Generally, most cases of lumbar spondylosis are considered mild, and the following treatment options are conventionally used:

• Chiropractice care

• Physiotherapy

• Anti-inflammatory/pain medication

• Light exercises, such as yoga or water aerobics, hot application,

counter irritant packs etc.

There are many ways to relieve pain, from drugs to surgery depending on the type of severity risk factors involved with using a particular treatment

10 and personal preference. Commonly used treatments for pain are Analgesics,

Opioids etc.

Since patients are prone to develop complications of Non-steroidal anti- inflammatory drugs, care should be taken regarding its toxicity in older patients. However, paracetamol may be tried initially as an analgesic in lumbar spondylosis. Other NSAIDs like Cox-II inhibitors can also be used. Locally applied NSAIDs are also useful but costlier.

Pain is often under treated with complimentary therapies. These type of therapies are followed which avoids unnecessary complications. The easy availability of mustard , it’s medicinal properties to relieve pain and it’s low cost with less side effects and long term in topical application makes mustard plaster as an adjuvant therapy in reduction of pain among patients with joint pains. Sprains and muscle aches are believed to be relieved when a paste or poultice of mustard is applied on the affected area.

1.4 MUSTARD

Mustard is one of the oldest recorded spices according to records dating back to 3000BC. It was recognized both for its therapeutic value and condiment value, historically being used to treat scorpion bites, entomb kings and as a flavoring agent to disguise degraded food. Mustard is used as an emetic, and diuretic, as well as a topical treatment for inflammatory conditions such as arthritis and rheumatism (8)

Mustard seeds have been used in traditional folk medicine as a stimulant, diuretic, and purgative and to treat a variety of ailments including peritonitis and neuralgia. Mustards are still used today in mustard plasters to treat rheumatism, arthritis, chest congestion, aching back, and sore muscles. To make a mustard plaster, mix equal parts of flour and powdered mustard and spread it as a paste on a doubled piece of soft cloth. Apply mustard plaster to the affected area for a maximum of 15 minutes. (9)

Mustard seeds are the small round seeds of various mustard plants. The seeds are usually about 1 or 2 mm in diameter. Mustard seeds may be colored from yellowish white to black. The seeds can come from three different plants: black mustard, brown Indian mustard, and white mustard.

Mustard seed has been used internally and externally since ancient times. Mustard and its oil have been used as a topical treatment for rheumatism and arthritis, as a foot bath for aching feet, and in the form of plasters over the

12 back and chest to treat bronchitis and pneumonia. Internally, mustard seeds have been used as appetite stimulants, emetics, and diuretics.

Scientific Name(s): Sinapis alba L. (white or yellow mustard), Brassica nigra L. Koch (black or true mustard), Brassica juncea L. Czern. et Cosson

(oriental, leaf, or Indian mustard). Family: Brassicaceae.

Common Name(s): Mustard, black mustard, Indian mustard, leaf mustard, true oriental mustard, white mustard, yellow mustard etc.

Mustard acts as a counter-irritant when it is applied to the skin. A counter-irritant is an agent that causes blood vessels to dilate, or open up, increasing the supply of blood to the area. When a part of the body is infected, increasing the supply of blood and lymph fluid to the area is likely to facilitate healing, because the blood will carry oxygen, nutrients, and lymphocytes

(white blood cells to fight the infection) to infected cells, while lymph fluid will carry away waste products and toxins.

(Brassica) Topically, used as a poultice for bronchial pneumonia, pleurisy, arthritis, lumbago, aching feet, rheumatism, and as a counterirritant

(Natural Medicine Comprehensive Database, 2003) To treat inflammation and joint pain (Skidmore-Roth L, 2004) (Natural Medicine Comprehensive

Database, 2003) Orally: No known suggested dose. No published research related to pain.

It is Generally Recognized as Safe (GRAS) status in the US (Natural

Can irritate asthma, and the GI tract Orally, large amounts of black mustard seed can lead to vomiting, stomach pain, diarrhea, somnolence, cardiac failure, breathing difficulties, coma, and possibly death (Natural Medicine

Comprehensive Database, 2003)

1.4.1 Health Benefits and Therapeutic Uses (10)

Since ancient times, people all over the world have used mustard for its medicinal properties. The high nutrient content in mustard helps the body to improve the metabolic process, lower blood pressure, and ward off atherosclerosis.

Mustard seeds have multiple benefits of antiviral, antimicrobial, antifungal, and anti-inflammatory properties. The antiseptic nature of mustard seeds helps to cleanse the digestive tract and improve the body's total immune mechanism.

The scent of mustard is considered to remove nasal congestion and help to clear up the lungs.

Mustard oil is also used for cooking as well as massage oil. It is considered to improve the circulation of blood through the body and ward off rheumatism and arthritis.

A plaster of mustard paste is also believed to help bring down fevers.

By helping to clear the sinuses of any phlegm or mucus, mustard is believed to mitigate the effects of asthma.

Selenium, that is present in mustard, is considered to help the body reduce its cholesterol levels.

The presence of Sulphur in mustard accounts for its use in treating skin ailments. The paste of the seeds is applied on the affected area for this purpose.

A gargle with mustard, honey, salt, lime, and hot water is believed to cure a sore throat.

A mustard soak or bath is also considered helpful in relieving back aches, muscle aches, and tired feet.

Brown mustard is considered to be aperitif, anodyne (a medication that alleviates pain), emetic, diuretic, stimulant and rubefacient and is a traditional medication for treating foot ache, arthritis, lumbago as well as rheumatism.

In China, the mustard seed is employed in treating tumours.

People in Korea use the mustard seeds in treating colds, abscesses, and rheumatism, lumbago and stomach problems.

In Africa, the brown mustard root is employed in the form of a galactagogue

(any medication that promotes the secretion of milk).

Taking mustard internally may pass on a body smell that repels mosquitoes.

1.5 FOMENTATION

As designated by Dr. J.H. Kellogg, Fomentation is an application of hot compress; usually a thick flannel cloth applied a number of times in succession at high temperature. Heat either with or without accompanying by a variety of other methods as by means of rubber bag filled with hot water. The exact effect of fomentation may be secured by wrapping a hot bag with a moist flannel cloth.

The method suggested by Dr.J.H.Kellogg consists of an ordinary fomentation in which mustard is added to the water employed in the proportion of a tablespoonful of ground mustard to the quart of water. It is not necessary to prepare a large quantity of water. Boiling water into which ground mustard has been thoroughly stirred in the proportion of a tablespoonful to the quart, and steeped for a few minutes, should be freely sprinkled upon the fomentation cloths, previously wrung out dry as possible, placed in basin or pail.

Hot Water Bag

Heat either with or without accompanying moisture may be applied by a variety of methods, as by means of a rubber bag filled with hot water. The exact effect of the fomentation may be secured by wrapping a hot bag with moist flannel cloth. Hot bricks bottles filled with hot water, and other heated objects may be used in a similar manner when it is desirable to employ heat for a considerable time.

The effect is that of a fomentation intensified by the addition of the chemical irritation of the mustard. The mustard fomentation is especially applicable to in which very quick and strong revulsive effect is desired, as for the relief of severe pain, or to secure strong derivative effects. (12)

Mustard is mentioned in the New Testament of the Bible five times, one time referred to as the greatest herb. The mustard plant has been used since ancient times and is valued for its oil content. It can be found growing wild in many parts of the world as it is widely cultivated. There are many varieties of mustard; they all have very pungent flavors. Some medicinal mustard compounds date back to at least 400 B.C. The name is derived from the Latin, mustum. Other names for mustard are white mustard, yellow mustard, pepper grass, and hedge mustard.

The mustard fomentation is especially applicable to case in which a very quick and revulsive effect is desired, as for the relief of severe pain, or to secure strong derivative effect. Care must; however, be taken to avoid excessive irritation or blistering of the skin. (13)

Evidences have been proved that application of mustard pack was very effective and safe on arthritis pain. However, the Mustard Pack is found to be a commonest treatment for low back pain in clinical practice. Yet there is no study conducted upon its efficacy for the low back pain associated with lumbar spondylosis. Thus this study is aimed at evaluating the effectiveness of hot mustard pack with fomentation on LBP in patient with lumbar spondylosis.

1.6 INCIDENCE AND PREVAILANCE

Furthermore, degenerative changes may appear in young individuals without decades of spine loading. Lawrence found 10% of women aged 20–29 to demonstrate evidence of disk degeneration. Lumbar spondylosis, while affecting 80% of patients older than 40 years, nevertheless was found in 3% of individuals aged 20–29 years in one study (14). The high incidence of degeneration among young and asymptomatic individuals highlights the challenge involved in establishing causality between imaging findings and pain symptoms in affected patients.

The point prevalence of LBP is 28.5% found in an Asian country (15).

The lifetime prevalence of low back pain is reported to be over 70%. But globally, the annual prevalence of LBP has been estimated at 38%. In general,

LBP resolves within weeks, but may recur in 24-50% of cases within 1 year.

The identification of risk factors for LBP is important in the prevention of recurrent and possibly chronic LBP. The prevalence of LBP in children is low

(1%- 6%) but increases rapidly (18%- 50%) in the adolescent population.

(16 - 18)

In accordance with the report of World Health Organization in 2002,

LBP constituted 37% of all occupational risk factors which occupies first rank among the disease complications caused by work. Such high prevalence of complications at international levels has made the World Health Organization to name the first decade of the third millennium as the “decade of campaign

18 against musculoskeletal disorders (as the silent epidemic)” (WHO, 2005) (19).

The yearly prevalence of low back pain varies from 5% to as high as 65% the lifetime prevalence has been placed between 35% and 37%.

Low back pain is a common complaint with the lifetime prevalence reported as ranging from 11% to 84%. The cause of pain is nonspecific in about 95% of people presenting with acute low back pain, with serious conditions being rare. Chronic low back pain is a well-documented disabling condition, costly to both individuals and society. (20)

Two thirds of the adult population suffers from pain in the lower back at some point in their lifetime. In Spain, the pathology affects four and a half million people, with a prevalence of almost 15 percent in the population of over

20 years of age. (21)

Labour Force Survey (LFS) in 2011/12 showed that there has been a reduction in the prevalence of work-related back disorders from 2,95,000 to 1,

76,000 world populations is affecting in a year. The majority of incidence which was to be estimated in 2011/12 was 51,000 cases, a fall from 95,000 cases in 2001/02 which is the highest estimated prevalence rates of back disorders. (22)

2.0 AIM AND OBJECTIVES OF THE STUDY

2.1 AIM

To evaluate the effectiveness of hot mustard pack with fomentation on low back pain in patients with lumbar spondylosis

2.2 OBJECTIVES

1) To assess the pretest level of low back pain among the patients with lumbar

spondylosis before application of HMPF

2) To assess the posttest level of low back pain among patient with Lumbar

spondylosis after application of HMPF

3) To correlate and document the effectiveness of HMPF by pretest and

posttest level of low back pain among patient with Lumbar Spondylosis

3.0 REVIEW OF LITERATURE

3.1 LUMBAR SPONDYLOSIS AND LOW BACK PAIN

Lumbar spondylosis can be described as all degenerative conditions affecting the disks, vertebral bodies, and associated joints of the lumbar vertebrae (23). Lumbar spondylosis includes numerous associated pathologies including spinal stenosis, degenerative spondylolisthesis, osteoarthritis and many others. It also encompasses effects of aging, traumata and just the daily use of the intervertebral discs, the vertebrae, and the associated joints (24).

Concerning older patients, the disease is said to be progressive and irreversible. Often is the lumbar region the most affected, because of the exposure to mechanical stress. The patient can also experience joint stiffness, which can limit motion. Patients with lumbar spondylosis also have neurologic claudication, which includes: lower back pain, leg pain, numbness when standing and walking.

Pain is an unpleasant sensation localized to a part of the body. It is often described in terms of a penetrating or tissue-destructive process and /or of a bodily or emotional reaction. (25) Low back pain refers to spinal and paraspinal symptoms in the lumbosacral region. “Acute” typically means a duration of less than 2 to 4 weeks, subacute is up to 12 weeks, and chronic typically refers to more than 12 weeks (26)

Udermann BE et al., 2004 conducted a study whether a patient educational book can change behaviour and reduce pain in CLBP patients. The study results suggest that a treat your own back book may have considerable efficacy in helping readers decrease their own low back pain and reduce the frequency of, even eliminate, their recurrent episodes (27)

Williams et al., 2009 evaluated the effectiveness and efficacy of Iyengar yoga therapy on CLBP. The yogic intervention consisted of 90 minutes class each week for 16 weeks and participants were encouraged to practice yoga at home for 30 min, 5 day a week. The results showed that yoga improves functional disability, pain intensity and depression in adults with CLBP. (28)

Low back pain is most prevalent during young and middle adult lives, between the ages of 25 and 55. It is noted that the incidence of low back pain is on an increase in a geometrical progression in the last few decades and has been designated as the new epidemic. The scale of the ‘back pain epidemic’ is alarming and has enormous economic implications.

Low back pain is the commonest orthopedic problem amongst population and a major cause of disability. It occurs in similar proportions in all cultures, interferes with quality of life and work performance, and is the most common reason for medical consultations (29 - 32).

The etiology of LBP is complex, and the causes are not clearly known; although some risk factors are implicated,(33) weakness and lack of motor

22 control of deep trunk muscles, such as the lumbar multifiddus (LM) and transverses abdominis (TrA) muscles are common.(34,35).

Other causes are:

Aging - ligaments thicken and discs dry out with age and age related changes in the spine may lead to disorders that create pressure on spinal nerves.

Degenerative disc disease is an example of age related spinal disorder.

Daily life - Stress and emotional tension can cause muscles to tighten and contract, resulting in pain and stiffness.

Injuries and accidents - fracture of spinal bone, osteoporotic changes and post traumatic weakness.

Obesity - overweight induces pressure and stress on the back, especially low back such condition like intervertebral disc prolapse (IVDP) etc. (36)

Low back pain (LBP) is the leading cause of activity limitation and work absence throughout the world, and it causes an economic burden on individuals, families, communities, industry and governments and leads to decreased wages and productivity. (37) The estimated total cost for low back falls third highest after heart disease and diabetes. (38)

Low back pain is equally prevalent in both sexes although clinical courses differ. Jobs requiring physically heavy work, static work postures, frequent bending, twisting, lifting, forceful movements, repetitive work and contact with vibrations predispose to low back pain. Psychological factors such 23 as monotony and dissatisfaction at work are also implicated. History of previous low back pain is the single most useful predictor of future episodes of pain. (39)

It is important to understand that spinal disc degeneration is a normal part of aging, but not all causes of back pain are the result of this. In many cases management of the condition is encouraged using pain medications, physiotherapy, osteopathy and chiropractic techniques including ultrasound and electrical stimulation. The use of these thus enables the sufferer to engage in exercise regimes and rehabilitation. The aim of the treatment is to re-train the body to adopt better posture and optimised intersegmental load transmission.

Overall, management of the condition seeks to minimise or prevent the application of excessive stress upon the disc through better ergonomics and posture.

The 2013 global burden of disease study identified low back pain (LBP) as the greatest contributor to disability worldwide. Most cases of LBP appear to follow a chronic-episodic course, significantly impacting the health care system, individuals, and families. Chronic LBP is associated with a higher prevalence of myocardial infarction and coronary heart disease. It is possible that this association remains even when controlling for genetics and early shared environment.

A number of health related co-morbidities have been found to be associated with LBP including cardiovascular disease. Recent studies have

24 found that the prevalence of coronary heart disease is highest among individuals with spinal pain (concurrent LBP and neck pain) as opposed to LBP alone. Furthermore, chronic musculoskeletal and wide spread pains have also been associated with coronary heart disease. (40)

The lumbosacral region is the most important region in the vertebral column in terms of mobility and weight bearing. Mechanical disorders of this region cause LBP. Low back pain (LBP) is a highly common problem and causes much morbidity and socioeconomic loss in the community, with lifetime incidence rates reported between 50% and 90%. It is known that several complex factors affect the lumbar curve. Clinical observations suggest that aberrations of posture may play a role in the development of LBP. (41)

Acute episodes of back pain are usually self-limited. Patients with persistent or fluctuating pain that lasts longer than three months are defined as having chronic low back pain. The economic impact of chronic low back pain stems from prolonged loss of function, resulting in loss of work productivity, treatment costs, and disability payments. Psychosocial issues play an important role in guiding the treatment of patients with chronic low back pain.

In 2004, Child et al., conducted a study on clinical prediction rule to identify patients with low back pain by spinal manipulation. Consecutive patients with LBP were randomly assigned to receive manipulation plus stretching exercises for 4 weeks. The study conclude that the spinal manipulation clinical prediction rule can be used to improve movements (or)

25 flexibility for patients with low back pain. Yet another study conducted on short term spinal manipulation on pain/pressure threshold in patients with

CMLBP, showed that there is significant reduction in severity of after short term manipulation and spinal mobilization. (42)

Most population (male & female) suffer from lower back pain at some time in their lives. Common causes of low back pain includes, people who work in a prolonged flexed posture while sitting at a one place at a time, or the

“weakened warriors” who attempt to participate in activity without a proper training program.(43)

One study found that patients with chronic low back pain who have a reduced sense of life control, disturbed mood, negative self-efficacy, high anxiety levels, and mental health disorders. Nonpharmacologic therapies are effective in certain clinical situations and can be added to the treatment program at any time. (44)

Neck and back pain are common presentations in primary care. Many cases of neck and back pain are due to benign functional or postural causes but a thorough history and examination are essential to assess the cause (see separate articles Low Back Pain and Sciatica, Thoracic Back Pain and Neck

Pain (Cervicalgia) and Torticollis), any associated psychological difficulties

(eg, depression, anxiety or somatization disorder) and any functional impairment, including restrictions with work, leisure and domestic activities.

(45)

LBP is one of the most common symptoms and conditions motivating individuals to seek medical consultation. The effects of back pain on society are significant, both epidemiologically and economically, and this is likely to only further increase owing to a combination of shifting attitudes and expectations, medical management techniques, and social provision.

Hence, LBP must always be addressed as a complex disease in which it is mandatory that an accurate diagnosis of pain generators is determined before starting any treatment. Multidisciplinary approach is important in order to determine a strategy to solve the problem and not simply alleviate symptomatic pain. (46)

3.2 MUSTARD PLASTER AND PACKS

Arthritis Back Pain Relief: the active ingredient in mustard seeds which helps provide arthritis back pain relief as well as other arthritic joint pain is allyl-isothyocyanate. It is a counterirritant, meaning that when applied to an inflamed area it causes blood vessels to dilate, thus increasing blood flow to the affected area so that toxins can be more readily removed.

For arthritis back pain relief, this means increased blood flow to the affected area so that pain relievers, whether topic or oral, pharmaceutical or herbal, can be more readily absorbed. Mustard poultices have been reported for centuries as having pain relieving qualities often sought by patients looking for arthritis back pain relief, knee pain relief, or relief of other arthritic pain.

The most effective arthritis back pain relief is from mustard plaster, the mustard seeds must be mixed with a liquid to activate the counterirritant compounds. However, to prevent blisters or burning while seeking arthritis back pain relief, mixing the ground mustard seeds or mustard powder with flour helps to partially neutralize the burn. It has been said that using pure egg whites rather than water will prevent burns when using mustard plaster for arthritis back pain relief.

Mix mustard seed, flour, and egg white to make a paste, and then spread between two layers of light cloth such as muslin. Apply muslin patch for 15 minutes, then remove and wash skin with cool water to prevent burns. (47)

The Arthritis Foundation reports that two-thirds of people with arthritis have tried alternative therapies. The use of complementary medicine is more common among people in the world. Alternative therapies for arthritis include such as acupuncture, copper bracelets, glucosamine, chondroitin supplements, naturopathy (mustard plaster), yoga, chiropractic, homeopathy, hypnotherapy, medical herbalism and osteopathy.

Complementary medicines are used in a variety of ways; some people use them instead of conventional treatments, some alongside. Some people use them regularly and some intermittently. Evidence suggests that users of complementary medicine feels, non-toxic, holistic approaches to health, more over they’re ‘natural’, and harmless with less side effects, and is locally available in living area (48).

V. Hemavathy et al performed a pre experimental one group pretest and posttest study for OA at Sivananda Gurukulam Oldage home in kattankolathur, Chennai. In pretest out of 30 samples majority of them have severe joint pain 15 (50%) and 10 (33%) of them were having moderate knee pain and 5 (17%) have mild pain and none of them having no pain In posttest out of 30 samples majority of them got relieved from knee joint pain 8 (27%) and 18 (60%) of them were having mild knee pain and 4 (13%) have moderate pain and none of them have severe and extreme pain. The application of mustard plaster on knee joint pain among osteoarthritis patients in Sivananda

Gurukulam, kattankolathur in Chennai was effective.(48)

In an randomized study of 60 patients Dushyant Kumar et al evaluated and compared the effect of hot mud (group 1) and mustard applications (group

2) to knee in patients with OA. Group 2 showed significant reduction in

Womac. Good improvement was seen in group 2 in right extension, left extension, physical functioning, social well-being and general physical health compared to group 1. The study result suggested that both hot mud application and mustard application could be considered effective in patients with OA while mustard application is more effective than hot mud application.

It is clear that capsaicin and mustard oil, at the applied concentrations, evoke a neurogenic inflammation, since, after chronic denervation, they produce no dye accumulation when compared with untreated or solvent-treated tissues (Jancsoa et al., 1967; Szolcsanyi, 1996a, 1988). These agents are selective sensory stimulants and the major subgroups of cutaneous receptors that they stimulate are the C-polymodal nociceptors.

Mustard oil application inhibited not only neurogenic plasma extravasation elicited by mustard oil or capsaicin but also non-neurogenic oedema formation evoked by dextran in the chronically denervated contralateral hindleg. (Selye, 1965).

Mustard plaster was first used in Europe centuries both culinary purpose and medicinal use it was introduced to other countries by European settlers,

Later by in US Army but use of mustard plaster became uncommon in late half of twentieth century. To find holistic treatment with effective pain relief and

30 few side effects, Americans spend billions of dollars annually on complementary and alternative medicine, including herbal therapies.

Despite extensive use, the lack of regulatory scrutiny of these herbal supplements contributes to the paucity of reliable clinical data assessing their efficacy and safety. MEDLINE, AMED, and the Cochrane Library databases were searched for the period from January 1966 to June 2005. Uses, dosages, routes of administration, and side effects were summarized. Strength of empirical evidence also was evaluated. The review found few well-controlled clinical studies.

Fredrick (2009) conducted the study to determine the effectiveness of mud therapy for 57 patients with bilateral primary knee pain, 32 of the patient received daily mud pack treatment on weekdays only for 3 weeks. The mud pack treatment was applied to both the knees for 30 minutes at 45oC, the remaining 25 patients, serving as control group, were given acetaminophen

(2g/day). The results suggested that mudpack treatment significantly reduced the level of pain and improved functional status of patient with knee joint pain.

According to book content of Modern Hydrotherapy for the Massage

Therapist 2007 pg 102; A plaster is a paste like mixture, usually of herbs, that can be spread upon a cloth and applied to the body. Ground mustard seeds contain chemicals and enzymes that, when combined with water, liberate compounds that encourage blood flow to the surface of the skin.

The plaster also functions as a counter irritant, a sub-stance that stimulates nerve endings on the skin, distracting the central nervous system from deeper-seated pain and relieving it. Plasters made with ground mustard are used to warm muscle tissues, especially deeper tissues, and to treat chronic aches and pains. Use of plasters became less common in the last half of the twentieth century, and they are now seen chiefly as a home remedy.

Originally mustard plasters were thought to draw out bad humors.

Practically speaking, however, the plasters were used to provide soothing heat, increase local circulation, relieve arthritis pain, and treat respiratory ailments such as chest colds and bronchitis by deeply warming the chest. Today’s massage therapist may wish to use a mustard plaster before massage to ease painful muscle or joint and to bring heat to a deeper muscle before it is massaged. Mustard plasters are indeed very hot and can even cause blistering, so you must monitor the skin underneath them carefully and take the plaster off at the recommended time. Mustard plaster are used to treat inflammation and joint pain (Data from Skidmore-Roth, 2004)

Research studies of Hungan Yangulo Department of Surgery, Faculty of

Medicine, Baskent University, 06490 Ankara, Turkey & Feza Karakayali

Department of Surgery, Diyarbakir Education and Research Hospital, 21400

Diyarbakir, Turkey Published online May 20, 2012 Pubmed application of mustard plaster to the affected area for a maximum of 15 minutes only.

Prolonged application can result in burns to the skin and nerve damage. Skin

32 lesions occur within hours after exposure, and there is no significant therapy procedure.

Dr.John Abramson is a researcher and faculty instructor of Naturopathy at Harvard Medical School in his book OVERDOSED AMERICA: The Broken

Promise of American Medicine September 2012 says not to apply mustard plaster directly to the Skin, to wrap the paste in a cloth, not leave on the skin longer than 10 to 15 minutes, to not use a mustard poultice on sensitive or broken skin. A mustard poultice is good for arthritic joints and any condition that requires increased circulation. It can be applied to the chest to help relieve congestion, aid asthma, relieve coughs, and assist in getting rid of colds and flu.

A study was conducted at Kayalvarath health complex in 2010 to determine the effectiveness of mustard plaster in reducing the knee joint pain.

The study group consists of 60 clients. Mustard plaster was applied and hot water application given. Post procedural pain score indicated a significant reduction in joint pain among client.

A study conducted by Dhivya et al in 2012 unpublished, in her study 60 elderly were selected and for whom mustard plaster was applied for knee pain for seven continuous days major findings of the study was Most the elderly were moderately (60%) satisfied with mustard plaster application and significant percentage (40%) of them were highly satisfied.

De Paepe K et al. 2002 studied the effects of rice starch on the skin of atopic patients. The beneficial effect rice is it acts as a skin barrier function in patients with atopic dermatitis and as a skin repair for barrier damaged skin, particularly in the case of atopic dermatitis patients. It's also a good anti- inflammatory and skin whitening agent that soothes sunburned skin and makes skin smooth and fairer. Rice can be mixed with fomentation packs to soothing the skin.

3.3 HOT PACKS

A wide range of non-invasive therapies have been evaluated for chronic low back pain including pharmacologic therapies, physical therapies and mind-body therapies (e.g., yoga, tai chi, cognitive behavioral therapy, mindfulness-based stress reduction, acupuncture). Non-pharmacologic interventions include, in acute cases, active care, spinal manipulation, and superficial heat (eg, hot packs).

Application of Heat: Low-quality evidence shows that in the first five days of acute low back pain, the use of heat treatments may be more effective for reducing pain and disability than nonheat wraps, NSAIDs, or acetaminophen. A low-quality study found that heat therapy in conjunction with education or NSAIDs is more effective than education or NSAIDs alone at

14 days (49, 50)

Alternative therapies can help ease muscle tension, correct posture, relieve pain, and prevent long-term back problems by improving muscle 34 strength and joint stability. Many people find pain relief by using hot and cold packs on the sore area. Special exercises, such as ones designed for your specific problem by a physical therapist, can help strengthen your core abdominal muscles and your back muscles, reducing pain and making your back stronger. (51)

Different healthcare disciplines commonly use heat and cold treatments for the treatment of low back pain.(52-59) Both therapies are simple to apply and are inexpensive. They may be used by people with low back pain at home or may be employed by practitioners as part of a treatment regimen.

Traditionally, ice has been recommended for acute injury and heat has been recommended for longer-term injuries. Superficial heat methods convey heat by conduction or convection.

Superficial heat elevates the temperature of tissues and provides the greatest effect at 0.5 cm or less from the surface of the skin. However, deep heating is achieved by converting another form of energy to heat, for example, shortwave diathermy, microwave diathermy, and ultrasound. Superficial heat includes such methods as hot water bottles, heated stones, soft heated packs filled with grain, poultices, hot towels, and hot packs.

The U.S. Agency for Healthcare Research and Quality guidelines found no evidence of benefit from the application of ice or heat for acute low back pain, however, recommended self-application of heat or cold for patients to provide temporary relief of symptoms. (60)

Before working with an area that needs concentrated stretching, deep heat from a hydrocollator pack, fomentation, hot compress, moist heating pad, hot water bottle, mustard plaster, or castor oil pack makes tissues far more pliable and stretchable. Local heat relaxes both skeletal and smooth muscles.

(Hot fomentations, hot sitz baths, and even electric blankets can relieve kidney stone pain, which is caused by a spasm of the smooth muscle that lines the ureter.)

According to Agnes Strickland et al. 2007 local heat also makes myofascial trigger points less painful to pressure while they are treated, and reduces muscle soreness from trigger point treatment when it is applied immediately afterwards. It improves local circulation and relieves the joint stiffness and discomfort of osteoarthritis. Hot applications can be combined with cold ones to form contrast treatments to stimulate local circulation and relieve pain. Finally, the soothing and nurturing feel of local heat helps reduce nervous tension.

De Paepe K et al., has stated, many local heat treatments such as dry heating pads, hot water bottles, and rice-filled microwaveable bags can be administered without the use of water and have many of the same effects, water is more efficient at transmitting heat than dry materials.

Therapeutic heat can help relieve musculoskeletal pain and promote mental relaxation and increased local circulation, as well as helping to warm and soften stiff muscles before exercise and stretching.

3.4 PAIN, DISABILITY AND ROM ASSESSMENT METHODS

In several investigations, VAS for assessing pain affect has shown to be valid and sensitive to treatment effects and to have ratio scales qualities. (61)

Clinical assessment for individuals with LBP has traditionally relied on tests of disability which has been reported to correlate poorly with patients’ pain and dysfunction.

Evaluating the disability of patients with LBP requires selecting appropriate disability measures. A key disability measure for studying patients with LBP is a self-report questionnaire which entity dependent on patient’s subjective feelings including: Roland Morris disability questionnaire, Oswestry

Disability Index (ODI), and Quebec Back Pain Disability Scale. (62) However most of patients’ self-reports of disability may not be adequate in making precise judgment of their condition without the objective evaluation of their physical performance. (63)

In 2008, a study was conducted on effects of spinal flexion and extension exercises and their associated postures in patients with acute low back pain. The results showed that there were no difference in any outcomes variables between the flexion or extension exercises groups, but theses exercise groups were found to be slightly more effective than no exercise. (64)

A study was conducted on comparing total lumbo-sacral flexion and lumbar flexion measured by a dual inclinometer technique on 75 subjects with

CLBP. Results suggested that total flexion seems to be more relevant to 37 outcome variables. But after intensive rehabilitation, total lumbosacral flexion significantly improved lumbar flexion in the measurement of trunk mobility in

CLBP. (65)

Paraesthesiae or pain in root distribution is very significant, indicating nerve root irritation assessed by neural tension tests. A positive result on the same side as the pain is said to be about 80% sensitive but only 40% specific; a positive result with the unaffected leg is said to be only 25% sensitive but 75% specific. Back pain suggests, but is not indicative of, a central disc prolapse and leg pain suggests a lateral protrusion. Pain must be below the knee if the roots of the sciatic nerve are involved. Lower the leg until pain disappears and then dorsiflexion the foot. This increases tension on the nerve roots, aggravating any pain or paraesthesiae (positive sciatic stretch test).

Spinal range of motion is a routinely method for LBP assessment, however there is a lack of evident correlation between impaired spinal mobility and level of disability in patient with chronic LBP. The use of range of motion scores to make inferences about a patient’s level of permanent disability in chronic low back pain requires evidence of criterion-related validity, if the validity was approved, range of motion could be used to predict the level of disability in LBP patients.(66).

Lumbar ROM is essential for evaluation of spinal functions; seek appropriate treatment and monitor patient progress. Schober's test is the most widely used and universal test for measuring lumbar sagittal ranges. Of the

38 many different methods used for assessment, Schober's test (67) is the most widely used and universally accepted. Moreover, the test is repeatable and hence can be used for assessment of prognosis. (68)

During lateral flexion measurements, the patients stood parallel to a wall to avoid substitution pattern of forward trunk flexion. Reading was taken from the inclinometer. The positioning frame was leveled at the upper measurement point and directed to zero, the patient was instructed to slide his hand down the side of his thigh while maintaining his weight over the other leg and foot. (69)

One senior orthopedic surgeon who was blinded about the MRI findings evaluated the clinical symptomatology and recorded the findings according to a detailed performa citing visual analogue score (VAS), pain drawings, Oswestry

Disability Index (ODI), neurological examination pertaining to root irritation and root compression signs. Predominant complaint of root pain was taken as leg pain and-/or parasthesia approximating to dermatome distribution radiating to ankle or foot and greater than low back pain, and pain with intermittent history or with periods of remission, positional and postural relief.

Root irritation signs were taken as restricted straight leg raising (SLR), well leg raising, and Lesegue test or bowstring test. The most important feature of nerve root irritation was taken to be the reproduction of leg pain, from any of the above mentioned test. Root compression signs were considered when there was muscle weakness, muscle wasting, sensory impairment to fine touch and reflex depression approximating to myotomal or dermatomal pattern. (70)

SLR test has been used as the primary test to diagnosis lumbar disc herniation’s and found to have high correlation with findings on operation since it's sensitivity is high in only disc herniation leading to root compression

(Majlesi et al., 2008).

Good measuring instruments are expected to be reliable; therefore this study determined the reliability of two instruments for measuring straight leg raising (SLR), which were the tape measure and universal goniometer. The two instruments were found to be reliable, with the goniometer having a higher value. Goniometer was more reliable than the tape measure and hence preferred for range of motion measurement. (Ayodeji A. Fabunmi et al, 2010).

4.0 NEED FOR THE STUDY

A physically active individual lives much healthier and active life than people who are physically inactive. This is true for everyone but especially for people with LBP. Pain particularly experienced by individuals is one of the most common clinical situations which encounter health professionals.

There are many ways to relieve pain, from drugs to surgery depending on the type of severity risk factors involved with using a particular treatment and personal preference. Commonly used treatments for pain are Analgesics,

Opioids, etc. Pain is often under treated treatment with complimentary therapies can be followed which avoids unnecessary complications.

Pain and stiffness are the main features and it may result in deformity and disability. So people are commonly worried about the pain. People with

LBP need pain management & easier movement. The need for the study is to reduce the dependence of individuals on the Over the Counter (OTC) medications to reduce LBP by introducing the home remedies, thereby reducing the side effects of the OTC drugs and to improve the quality of life.

Pharmacological management of LBP is usually by using Non-steroidal anti-inflammatory drugs (NSAID). Since patients are more prone to develop complications of NSAID, physicians should be careful in selecting proper drugs on individual basis looking into the cost, efficacy and toxic profile.

However, paracetamol may be tried initially as an analgesic in osteoarthritis.

Other NSAIDs can also be used for enhanced effect with less side effects like 41 newer selective cyclo-oxygenase II (Cox-II) inhibitors. Locally applied

NSAIDs are also useful but costlier.

The easy availability of mustard, its medicinal properties to relieve pain and it’s low cost with less side effects and long term in topical application makes mustard pack as an adjuvant therapy in reduction of pain among elderly with joint pains, low back pain etc. Sprains and muscle aches are believed to be relieved when a paste or poultice of mustard is applied on the affected area.

5.0 METHODOLOGY

4.1 SUBJECTS:

Thirty subjects of both genders (male and female) with low back pain of ages ranging between 25 – 70 with known case of Lumbar Spondylosis (both acute and chronic Low back pain)

4.2 STUDY GROUP

The study group subjects were obtained from the Outpatient Department of Government Yoga and Naturopathy Medical College & Hospital,

Arumbakkam, Chennai.

4.3 INCLUSION AND EXCLUSION CRITERIA

4.3.1 Inclusion Criteria

• Subjects of both gender (male and female) with low back pain of ages

ranging between 25 – 70 with known case of Lumbar Spondylosis (both

acute and chronic low back pain)

• Patients under medication / Non medication

• Willing to participate in the study by signing the written informed consent

proforma

• Patients residing in Chennai

• Able to visit the center (GYNMCH) thrice in a week

4.3.2 Exclusion Criteria

• Ingested pharmacological procedures - analgesic drug within 24 hours

• Direct impact trauma & Epileptic attack

• Any known chronic infection, such as Hepatitis, tuberculosis

• History of inflammatory arthritis of large joints

• Patients with Ankylosing spondylosis, Rheumatoid Arthritis, cancer, HIV

and pregnant women.

• Alcohol or substance abuse

• Age <25 and > 70 years

• Sensory or motor deficit in lower limb

• Epigastric pain

• Fever >38 degree Celsius

4.3.3 Ethical Considerations

The subjects were recruited and informed about study protocol and assessment procedures for the study group. They were also given the details about the interventions. All subjects signed the informed consent a sample copy is enclosed in the Annexure I (English version) and Annexure II (Tamil version). Approval was obtained from the Institutional Ethical Committee, as all tests are essentially non-invasive in nature. 44

4.3.4 Study Setting

4.3.4.1 Setting for Assessment and Interventions

Thirty subjects were randomly assigned and were diagnosed for lumbar spondylosis by confirming the following key elements with the patients:

- Mechanism of injury

- Acute traumatic, overuse, or spontaneous onset

- Location of pain

-Radiation of pain to buttocks, leg, foot

- Numbness or tingling

- Provoking/alleviating factor

- Pain with lumbar flexion, extension, or both

- Increased pain with cough, sneeze

- Effect on activity, work, or exercise

- Medications used for back pain.

Thirty subjects were randomly assigned and recruited for the experimental study. The subjects were included with respect to the inclusion and exclusion criteria. The selected subjects were assessed for pain and disability using Visual Analogue Scale (VAS) and Revised Oswestry Disability

Index (RODI). Additionally subjects were also assessed by Neural Tension 45

Test (NTT) like Straight Leg Raising (SLR) and bowstring test, and the Range of Motion (ROM) is assessed using Modified Schober test which measures lumbar flexion and extension. The subjects were instructed regarding the procedure of the treatment and the subjects underwent treatment thrice in a week for four weeks. All the subjects in the study were assessed before and after (Pre and Post) the treatment.

4.3.5 Design

4.3.5.1 Pre and post Experimental study: The selected subjects were recruited to visit Outpatient department for prospectively thrice a week for four weeks. All the subjects were treated with HMPF for the study period. Hence the present study followed an experimental test with the study group.

Assessment was done before and after with the above mentioned intervention group

The subjects were subjected to hot mustard pack with fomentation, thrice in week for four weeks. The study Groups Assessment was done before and after treatment completion.

4.3.5.2 Data Points

The data collection was done on day 1 before commencing the treatment

(baseline data) at the 4th week after completion of treatment interventions. This is illustrated below as Figure 4.

Figure 4: Illustrations of Data points

HMPF THRICE A WEEK FOR 4 WEEKS

Pretreatment Post treatment (Baseline data) (End point data)

4.3.5.3 Trial Profile

. Recruitment of potential subjects

. Baseline data collection

. Pre intervention: Assessment by VAS, RODI, NTT and ROM score.

. Intervention - Application of HMPF

. Post intervention: Assessment by VAS, RODI, NTT and ROM score.

. Interpretation and data analysis: by SPSS, Two Sample Paired T Test

and chi-square test.

. Results & Conclusion

Figure 5 - The trial Profile of the study illustrating the study plan.

POTENTIAL SUBJECTS WERE RECRUITED

SUBJECTS MET INCLUSION AND EXCLUSION CRITERIA (n =30)

PRE TEST ASSESMENT OF RECRUITED SUBJECTS

(VAS, RODI, NTT, ROM)

BASELINE DATA (DAY 1)

TREATMENT WITH HMPF (THRICE A WEEK FOR 4 WEEKS)

END POINT ASSESSMENT

(AFTER 4 WEEKS)

DATA EXTRACTED FROM THE SUBJECTS - ASSESSED RESULTS (VAS, RODI, NTT, ROM)

STATISTICAL DATA ANALYSIS & RESULTS

4.3.6 Assessment of Study

Data extraction and collection was done at baseline and post- intervention from the outpatients of GYNMCH for which the following assessments under the following tools were done.

4.3.6.1 Pain Assessment:

4.3.6.1.1 Visual Analogue Pain Scale (VAS)

The methodology most commonly used for the evaluation of pain severity and relief, is the VAS (Annexure 3) (40) It is easy to use, provides reproducible results and is applicable to a variety of practical settings.(41)

VAS is a reliable, valid instrument to assess pain intensity and is selected as the outcome measure based on its ability to detect immediate changes in pain.(42,43) Various studies have been conducted to determine the reliability and validity of the visual analogue scale for disability in patients with musculoskeletal pain.

Pain intensity can be defined as how much a patient is hurt by his or her low back pain. The two most commonly used methods to assess of pain intensity are the visual analogue scale (VAS) and numerical rating scale (NRS).

A VAS consists of a line, usually 10 cm long; with ends labeled as the extremes of pain (e.g. ‘no pain’ to ‘worse pain’).

Specific points along this line might be labeled with intensity-denoting adjectives or numbers. Patients are asked to indicate which point along the line

49 best represents their pain intensity and the distance from the no-pain end to the mark made by the patients is the patient’s pain intensity score. Pain intensity scores as measured by the VAS correlated positively with other self-reported measures of pain intensity. (44)

Beurskens et al, (45) assessed the responsiveness of the VAS in patients suffering from non-specific low back pain for at least 6 weeks using the optimal cut-off point. The patient’s global perceived effect was considered to be the golden standard. It appeared that using a cut-off point from 10 to 18 mm on a VAS for pain intensity discriminates best between patients who were improved and patients who were unchanged.

Figure 6: Visual Analogue Scale for Pain Assessment

4.3.6.2 Disability Assessment

Revised Oswestry Disability Index (RODI)

The RODI (Annexure 4) was first designed in 1980 by Fairbank et al. to assess low back pain disability and was subsequently revised in 2000. It has been widely used and validated for thoracic and lumbar spine pain. (50)

Outcome measures of disability caused by back pain are key in assessing the effectiveness of surgical and non-surgical treatment options as well as in comparing treatment-associated risks and benefits. RODI is a well-accepted measurement of disability in patients with back pain and has been used in hundreds of studies.

The questions in this questionnaire are designed to give information about the low back pain or leg pain that affect the ability to perform everyday activities (51). This is a self-report questionnaire; the patients are instructed to fill it out. The patient follows the general instructions given at the top of the questionnaire.

Each section should be completed. If the patient leaves one blank, they will be instructed to complete the questionnaire. It must be completed in one sitting. The questionnaire consists of totally 10 sections each carrying 6 questions. Each section has 6 possible answers. The marks for question in each section ranges from 0-5. The marks are 0,1,2,3,4 and 5 for the 1,2,3,4,and 5th answers respectively. Statement 1 is graded as 0 points; statement 6 is graded as 5 points. A total score of 50 is thus possible and would indicate 100% 51 disability. So, for example, a total score of 10 of a possible 50 would constitute a 20% disability. (52). The questionnaire sample is attached as Annexure 4. a) Scoring the questionnaire (53)

Score: patient score / total possible score x 100 = % disability b) Scoring:

For each section, the total possible score is 5

If the first statement is marked, the section score = 0

If the last statement is marked, it = 5.

If all ten sections are completed the score is calculated as followed:

Example:

• 16 (total scored by patient)

• 50 (total possible score)

• 16/50 x 100 = 32%

If one section is missed or not applicable, the score is calculated as followed:

Example:

• 16 (total scored)

• 45 (total possible score)

• 16/45 x 100 = 35.5% 52 c) Interpretation of % Scores

The following interpretation of disability scores is excerpted from the developers of the Oswestry system (457):

0%-20%: Minimal disability

This group can cope with most living activities. Usually no treatment is indicated, apart from advice on lifting, sitting posture, physical fitness, and diet. In this group some patients have particular difficulty with sitting, and this may be important if their occupation is sedentary, e.g., a typist or lorry [truck] driver.

20%-40% Moderate disability

This group experiences more pain and problems with sitting, lifting, and standing. Travel and social life are more difficult and they may well be off work. Personal care, sexual activity, and sleeping are not grossly affected, and the back condition can usually be managed by conservative means.

40%-60%: Severe disability

Pain remains the main problem in this group of patients, but travel, personal care, social life, sexual activity, and sleep are also affected. These patients require detailed investigation.

60%-80%: Crippled

Back pain impinges on all aspects of these patients’ lives both at home and at work and positive intervention is required.

80%-100%

These patients are either bed-bound or exaggerating their symptoms.

This can be evaluated by careful observation of the patient during medical examination.

It is recommended that clinicians focus their discussions of the results with patients in positive terms, rather than reporting disability scores. For example, point out the 10% improvement on a subsequent test.

4.3.6.3 Range Of Motion (ROM) Assessment

Range of Motion is the arc of motion that occurs at a joint or a series of joints. (46) ROM is a basic technique used for the examination of movement and for imitating movement into a program of therapeutic intervention. With the subject standing erect, two marks were linked on the skin of the lateral trunk.

The upper trunk mark represents the intersection of a horizontal line through the xiphisternum with the coronal line. The lower mark presents the intersection of a horizontal line through the highest point on the iliac crest with the coronal line. The distance between these two marks was measured in

Inches. At the end of this movement the distance between the two marks was again measured. (47)

Movement that is necessary to accomplish functional activities can be viewed, in its simplest form. When a person moves, the intricate control of the muscle activity that causes or controls the motion comes from the central nervous system. The structure of the joints, as well as the integrity and flexibility of the soft tissues that pass over the joints, affects the amount of motion that occurs between any two bones. The full motion possible is called the range of motion (ROM).

When moving a segment through its ROM, all structures in the region are affected muscles, joint surfaces, capsules, ligaments, fasciae, vessels and nerves. ROM activities are most easily described in terms of joint and muscle range. Ranges of available joint motion are usually measures with a inch tape and recorded in degree and inches. (48) Muscle range is related to the functional excursion of muscles. Functional excursion is the distance a muscle capable of shortening after it has been elongated to its maximum.(49)

Modified Schober's test: When the spine flexes, the distance between each pair of vertebral spines increases. Schober's test can be used to provide a quantitative evaluation of flexion and extension of the lumbar spine.

a) Lumbar Flexion: A tape with a 15 cm mark is placed vertically in the midline upwards from the level of the dimples at the level of the posterior

55 superior iliac spines). Mark the skin at 0 and at 15 cm and the patient was flexed as far forward as they can.

Record where the 15 cm mark on the skin strikes the tape. The increased distance along the tape is due only to flexion of the lumbar spine and is normally about 6-7 cm (less than 5 cm should be considered as abnormal). The recorded data were tabulated for statistical analysis.

b) Lumbar Extension: The patients were asked to arch their back; pain and restricted extension are particularly common in a prolapsed intervertebral disc and spondylosis. The new extended point was recorded from the previous zero mark

4.3.6.4 Neural Tension Tests a) Straight Leg Raising:

For straight leg raising tests, the patients were asked to lie with the spine on the table and to relax completely. With the knee fully extended, first one leg and then the other were slowly lifted and flexed at the hip. This produces stretch on the sciatic nerve, at which point sciatic pain is produced. If this maneuver produces pain in the hip or low back with radiation in the sciatic area, the test is considered positive for nerve root irritation. The angle of elevation of the leg from the table at the point where pain is produced was recorded using goniometer.

56 b) Bowstring test:

Once the level of pain has been reached, flex the knee slightly and apply firm pressure with the thumb in the popliteal fossa over the stretched tibial nerve. Radiating pain and paraesthesiae suggest nerve root irritation and confirms the test is positive.

4.3.7 Hot Mustard Pack with Fomentation (77)

Ingredients

Mustard Seed Powder

Rice flour

Requirements:

Cotton Cloth (muslin cloth)

Hot bag

Directions

• The mustard seed powder was finely ground. If lumpy, then ground till it is

fine.

• Add rice flour (40g) to the mustard powder (20g) and drizzle in a little hot

water to make a paste.

• The paste mixture should be easily spreadable and not be thick or watery.

• Sterilize the cloth by boiling it in water. Squeeze out excess water and place

on a clean cutting board

• Spread a thin layer of the mustard paste on the cloth and then place the

mustard pack on the lower back.

• To this fomentation (Temp. about 102 ° Fahrenheit) is applied by a hot bag

for about 15 – 20 minutes.

• After the treatment remove the pack and wash the area with water.

4.3.8 Data Extraction and Analysis

4.3.8.1 Data Extraction

The data was collected from the recruited subjects as treatment outcome variables and the data before and after treatment were compared. The assessments were done on the first day of treatment before starting the treatment and on the final day of treatment after completing the treatment. The data was organized in Microsoft Excel sheets (version.2007).

4.3.8.2 Data Analysis

Statistical analysis of the data was done using SPSS statistics (Version

20 Release 20.0) software package. Data was checked for mean score collected within the group, which was analysed by paired t test and chi square test.

6.0 RESULTS

The present study was conducted to evaluate the Effectiveness of Hot

Mustard Pack with Fomentation on patients with Lumbar Spondylosis viz., pain intensity, disability index, neural tension tests, range of movements, as outcome variables in reducing pain of lower back in patients recruited for the study. Data was extracted both at the baseline (before treatment) and at the end point (after treatment). The obtained data was compared between before and after intervention of treatment to evaluate the effectiveness of HMPF.

Thirty participants (female - 36.7% and male – 63.3%) were recruited.

The mean age of the participants was 52.1 years. Paired t-test showed significant reduction in pain (9.67±0.55 versus 0.77±0.82, p<0.001) and significant reduction in disability (37.30±3.44 versus to 6.13±4.36, p<0.001) as in Table 1.

The MODI score for disability using chi-square test. This showed that, all patients were crippled (n=23) or bed-bound (n-7) at baseline whereas after treatment patients were mostly minimal (n=28) or moderate disabled (n=2), p<0.01 as shown in Table 2.

Range of Motion for the pre and post treatment was measured using

Modified Schober Method. The Table 3 illustrates lumbar flexion data of 2.59

± 0.52 for pretest and 6.34 ± 0.66 for the post treatment. The lumbar extension test was 1.20 ± 0.09 and 2.09 ± 0.11 for the pre and the post treatment respectively.

The neural tension test – straight leg raising and bowstring sign were observed, and statistically analysed. The straight leg raising test, for right leg

(33.5±10.99 versus 80.33±1.96, p<0.0001) and for left leg (36±11.48 versus

83.67±8.4, and the value of p<0.0001 and the results are shown in table

3 and 4.

The bowstring sign test for pre and post are tabulated in table 5 and 6.

The bowstring data was 18 (60%) and 5 (16.7%) with p < 0.05 for the pre and post-test respectively for the right leg and 19 (63.3%) and 2 (6.7%) p= NS for the pre and post-test respectively for the left leg. The bowstring sign data was assessed by Chi-Square test. The results of pre and post treatment for both right and left leg showed decrease in disability. For the right leg the percentage reduced from 60 to 16.7% and for the left leg the percentage reduction was from 63.3 to 6.7%. The p value <0.05 indicates the precision in data for all 30 subjects. .

The overall effects of the variable before and after treatment are grouped together and listed in Table 7.

TABLE 1 - Mean, Variance, Median and Standard Deviation

For Pain and Inability

Standard Parameter N Mean Variance Median P.value deviation

Pre 30 9.66 0.29 10 0.54 Pain <0.0001 (VAS) Post 30 0.76 0.67 1 0.81

Pre 30 37.3 11.87 37.3 3.44

RODI <0.0001

Post 30 6.13 19.01 6.133 4.30

Graph 1: VAS and RODI variable PRE and POST treatment

37.3 40

15 9.66

10 6.13

5 0.76

0 VAS (PRE/POST) ODI (PRE/POST)

Table 2: Disability based on MODI score and analysed using chi-square test

Variable Pre-test, n (%) Post-test, n (%) p-value

Disability score (ODI)

Minimal Disability 0 28 (93.3)

Moderate 0 2 (6.7) Disability <0.01

Severe Disability 0 0

Crippled 23 (76.7) 0

Bed-bound 7 (23.3) 0

Graph 2: Disability based on MODI score-analysed using chi-square test.

TABLE 3 - Mean, Variance, Median and Standard Deviation

of Lumbar Flexion and Extension

Standard Parameter N Mean Variance Median P value deviation

Pre 30 2.59 0.29 2.53 0.52 Lumbar <0.0001 flexion Post 30 6.34 0.27 6.50 0.66

Pre 30 1.19 0.01 1.20 0.09 Lumbar <0.0001 extension Post 30 2.09 0.01 2.1 0.11

Graph 3: Lumbar Flexion and Extension variable

Pre and Post Treatment

LF - LUMBAR FLEXION 7 6.35 LE - LUMBAR

6 1

5 2

2.59 3 2.09

2 1.2

0 LF (PRE)/POST LE (PRE/POST)

TABLE – 4 Straight Leg Raising Variable Pre and Post Treatment

Pre Test Pre Test Post Test Post Test Variable P - Value Mean SD Mean SD

STRAIGHT LEG RAISING

Right Leg 33.5 10.99 80.33 1.96 <0.0001

Left Leg 36 11.48 83.67 8.4 <0.0001

Graph 4: Straight Leg Raising Variable Pre and Post Treatment

83.67 90 80.33

50 RIGHT LEFT 36 40 33.5

0 SLR (PRE) SLR (POST)

TABLE – 5 Bowstring sign Variable Pre and Post Treatment

Pre Test Post Pre Test Post Test Test Variable Mean Mean (%) (%)

BOWSTRING SIGN

Right Leg 18 60 5 16.7

Left Leg 19 63.3 2 6.7

Graph 5: Bowstring Sign Variable Pre and Post Treatment

20 18

6 5 2

2 LEFT

0 RIGHT BOWSTRING (PRE) BOWSTRING (POST)

Table 6: Bowstring sign (%) calculated using Chi-Square test

Variable Pre-test, n (%) Post-test, n (%) p-value

Bowstring sign (+ve)

Right 18 (60%) 5 (16.7%) <0.05

Left 19 (63.3%) 2 (6.7%) NS

Graph 6: Bowstring sign (%) calculated using Chi-Square test

70 63.3 60 60

40 RIGHT LEFT

20 16.7

10 6.7

0 BOWSTRING (PRE) % BOWSTRING (POST) %

Table 7- Comparison of Effect of Pain, Disability,

NTT and ROM Variables Pre and Post Treatment

PRE-TEST POST- TEST VARIABLE P- VALUE (MEAN ±SD) (MEAN ±SD)

Pain score(VAS) 9.67±0.55 0.77±0.82 <0.0001

Disability score (ODI ) 37.30±3.44 6.13±4.36 <0.0001

Lumbar Flexion (in cm) 2.59±0.52 6.35±0.66 <0.0001

Lumbar Extension 1.20±0.09 2.09±0.11 <0.0001 (in cm)

Straight Leg Raising 33.5±10.99 80.33±1.96 <0.0001 (in degree), Right

Straight Leg Raising 36±11.48 83.67±8.4 <0.0001 (in degree), Left

Bowstring sign (+ ve) Right 18 (60%) 5 (16.7%) <0.05

Bowstring sign (+ ve) 19 (63.3%) 2 (6.7%) NS Left

Graph 7 - Pain, disability, NTT and ROM parameter before and after treatment

90 83.67

40 37.3 36 PRE-TEST POST- TEST 30

19 20 18

9.67 10 6.35 6.35 6.13 5 2.59 2 0.77 1.2 0 0 0

7.0 DISCUSSION

Collected data were analysed by using descriptive and inferential statistics and presented in form of tables and graph in results section. This chapter attempts to discuss the findings as per the objective.

Low back pain is common among all individuals with LS and even age groups. Day by day, a percentage of LS with low back pain patients are increasing all over the modern world and it is the main obstruction in daily life activities.

The main aim of the alternative medicine and rehabilitation programs in general is to improve the functional status of patients. Restriction of function in a patient referenced concept that is different for each individual. (78)

The investigation was to evaluate the effectiveness of Hot Mustard Pack with Fomentation before and after treatment in patients with lumbar spondylosis. We used self- reported VAS and RODI and additionally NTT and

ROM tests for LBP, these scales have been reported to be most satisfactory means of assessing pain and immediate flexibility.

LBP, which is red plagues for many people may have its origins in impairments that begin much earlier than its painful manifestation although decreased abdominal endurance has been found in both adolescent (mean age,

14.9yrs) and adult (mean age, 45.6yrs) populations with LBP.(79, 80)

In our present study, we found that males suffered more than the females and the age groups between 25 to 70 years are more prone for LBP because of

75 occupational and other life style changes. As per our statistical analysis results found that post treatment results show that there is significant reduction of pain and disability index in both males and females.

The reason for the analgesic effect is not yet implicit. A number of possible Research articles on mustard have stated it acts as a counterirritant and thus reduce pain. Hot packs and heat applications have also proved to reduce pain. The combined effect of mustard and hot pack may be a reason for the very effective result in relieving pain and decrease disability. This finding is supported by the study conducted at kayalvarath health complex in 2010 to determine the effectiveness of mustard plaster in reducing the knee joint pain.

The study group consists of 60 clients. Mustard plaster was applied and hot water application given. Post procedural pain score indicated a significant reduction in joint pain among clients and disability among recruited subjects.

Edward et al. in 1993 tried successfully mustard as a topical treatment for arthritis. The study group contained 90 arthritis clients. Mustard was applied over painful joint and massaged. The post procedural pain scores indicated a significant reduction in joint pain among participants.

The study concludes that the level of inability before application of Hot

Mustard pack with fomentation is (M= 9.67; SD = 0.55) and posttest

(M=0.77;SD = 0.82), it is noted that the difference is statistically significant at p < 0.0001 level which indicates that Hot Mustard Pack With Fomentation is

76 effective in reducing inability among lumbar spondylosis patients as illustrated in graph 1.

The percentage of inability before treatment was 0 for minimum, moderate and severe but 76.7% crippled and 23.3% bed-bound. The percentage reduced after treatment and was 93.3% minimal and 6.7%moderate and 0% for severe, crippled and bed bound, concluding that the bed-bound patients inability was reduced to minimal, indicating the inability among patients has been very significantly reduced after treatment as in graph 2.

According to results of the Modified Schober Test as showed in graph 3 the lumbar flexion and extension value before and after treatment reveals that the HMPF has tremendously improved the flexibility and ROM of the lower back without pain.

The straight leg raising (graph 4) results has improved from 33.5 -80.33 for right leg and 36 – 83.67 for left leg for pre and post-test respectively signifying that the treatment was very operative. The bowstring sign (graph 5 and 6) showed significant p value of >0.05 indicating the accuracy of data and decrease in the percentage of bowstring sign expressing the neural tension in the both the legs have declined leading to decreased pain and disability in lumbar spondylosis patients.

The black mustard also has properties like antibacterial and antifungal when used topically and its variety is useful in rheumatoid arthritis that decreases inflammation and pain of the joints and back aches. (81) 77

The difference in p<0.0001 statistically denotes that there is association and effectiveness in clinical variable after application of Hot Mustard Pack with Fomentation on lumbar region decreases pain and inability significantly with precision in data.

Thus from all the results it can be concluded that the treatment was very effective in plummeting pain, disability and increased lumbar flexion and extension thus enhancing range of motion in the lower back. The neural tension of both the legs was decreased after the treatment and the patient’s ability in straight leg raising has remarkably increased (graph 7).

The study was able to prove the hypothesis, with a statistically significant value between the pre and post treatment and a conclusion can be made that the Hot Mustard Pack with Fomentation is more effective in reducing the severity of pain and disability among patients with lumbar spondylosis.

8.0 CONCLUSION

The following conclusions are drawn from the study:

The Hot mustard pack with fomentation application could be useful, safe even for the elderly, and easily available to reduce pain. The excavated results supported that Hot mustard pack with fomentation may be one of best method to reduce the low back pain in patients with Lumbar Spondylosis. The hot mustard pack with fomentation has also shown that reduction of pain improves inability and also cost effective. So Hot mustard pack with fomentation can be advised in alternative medicinal treatment as one of the best method to reduce low back pain and improve disability in patients with Lumbar spondylosis

9.0 LIMITATIONS

In this study, the main limitation is the small sample size with low power significance in experimental study. Subjects of the study were the

Outpatients of GYNMC so limited to a small group.

Directions for future research:

 A prospective Randomized controlled trial would strengthen the

findings observed here.

 Large number of sample and extend of the study for 6-8 months would

help the researchers in generalizing the results.

 Long term follow up studies to find out the long term effect of Hot

Mustard Pack with Fomentation on Low back Pain can be designed.

 Same study can be done as experimental study for two groups.

 To conclude the effectiveness more advanced method like MRI or CT

scan can be used with groups after treatment to conclude the result more

precise for anatomical improvement of the spine if any.

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CASAZZA, MD, University of North Carolina School of Medicine, Chapel

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78. Pain Research and Treatment Volume 2012 (2012), Article ID

680496, 4 pages, Evaluation of Nonspecific Low Back Pain Using a New

Detailed Visual Analogue Scale for Patients in Motion, Standing, and Sitting:

Characterizing Nonspecific Low Back Pain in Elderly Patients

79. Yasuchika Aoki,1 Shiro Sugiura,2 Koichi Nakagawa,1 Arata

Nakajima,1 Hiroshi Takahashi,1 Seiji Ohtori,3 Kazuhisa Takahashi,3 and

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Pushpan & Rohini S AVT Institute for Advanced Research, Arya Vaidya

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Tamil Nadu Received 17 October 2008 revised 17 April 2009

11. ANNEXURE

ANNEXURE 1

INFORMED CONCENT FORM

Investigator:

Name of the Participant: OP/IP No.:

INTRODUCTION

You are invited to join a research study at Government Yoga and

Naturopathy Medical College, Hospital, Arumbakkam, Chennai, entitled:

“Evaluation of effectiveness of Hot Mustard Pack with Fomentation (HMPF) on patients with Lumbar Spondylosis”. Please take whatever time you need to discuss the study with your family and friends, or anyone else you wish to. The decision to join, or not to join, is up to you. In this research study, we are evaluating the effect of mustard pack on Lumbar spondylosis (LS) by questionnaire method.

WHAT IS INVOLVED IN THE STUDY?

If you decide to participate you will be asked to visit the research centre three times a week for 24 weeks, to take treatment. After completing the treatment you need to fill a form regarding the effect of the treatment. We think this will take you 40 minutes every time you visit the center.

The investigators may stop the study or take you out of the study at any time they judge it is in your best interest. They may also remove you from the study for various other reasons. They can do this without your consent.

If you do not follow the schedule or may have any untoward effect during the treatment you might be taken off the study. You can stop participating at any time. If you stop you will not lose any benefits.

RISKS

This study involves the application of mustard pack followed by fomentation for 20mts, so if your skin is sensitive you may get very mild irritation.

BENEFITS TO TAKING PART IN THE STUDY

It is reasonable to expect that:

Your low back pain will significantly reduce in the course of the treatment

You can actively take part in everyday activities (walking, bending, washing, etc.)

Others may benefit in the future from the information we find in this study.

CONFIDENTIALITY

We will take the following steps to keep information about you confidential, and to protect it from unauthorized disclosure, tampering, or damage. You have the right to confidentiality regarding the privacy of the medical information (personal details, results of physical examination, investigations and your medical history). By signing this document, you will be allowing the research team investigators, other study personnel, sponsors,

IEC or any person or agency required by law like the Drug Controller General of India, to view your data, if required.

The information from this study, if published in scientific journals, or presented at scientific meetings, will not reveal your identity.

INCENTIVES

You will not be receiving any incentive for participating in this research study.

YOUR RIGHTS AS A RESEARCH PARTICIPANT

Participation in this study is voluntary. You have the right not to participate at all or to leave the study at any time. Deciding not to participate or choosing to leave the study will not result in any penalty or loss of benefits to which you are entitled, and it will not harm your relationship with the members of the research center.

However, it is advisable; you talk to the research team prior to stopping the treatment.

CONTACTS FOR QUESTIONS OR PROBLEMS

If you have questions about the study, any problems, unexpected physical or psychological discomforts, any injuries, or think that something unusual or unexpected is happening please feel free to inform the investigator or research team.

CONSENT OF SUBJECT (OR LEGALLY AUTHORIZED

REPRESENTATIVE)

Signature of Subject or Representative Date

Upon signing, the subject or the legally authorized representative will receive a copy of this form, and the original will be held in the subject’s research record.

ANNEXURE 2

அர� ேயாகா ம쟍�믍 இய쟍ைக ம�鏍�வ埍க쯍�� ம쟍�믍

ம�鏍�வமைண, அ�믍பா埍க믍,ெசꟍைன- 106

ஆரா뿍母சிய�쯍 ேசர வ��믍�த쯍 ேவ迍� ஒꯍ�த쯍

வ�迍ணꯍப믍

அர� ேயாகா ம쟍�믍 இய쟍ைக ம�鏍�வ埍க쯍��

அ�믍பா埍க믍 ெசꟍைன-106 ஆரா뿍母சிய�쯍 த柍கைள

இைண鏍த쯍 ெதாட쏍பாக- எ柍க쿍 க쯍��ய�쯍 வழ柍கꯍபட

இ�埍�믍 �� க��ப翍� சிகி母ைசய�ꟍ ெசய쯍 திறꟍ

அ�ꯍபைடய�쯍 த柍கைள எ柍க쿍 ஆ뿍வ�쯍

இைண鏍�埍ெகா쿍ள வ��믍�கிேறா믍, இꏍத ஆ뿍வ�쯍

த柍கைள இைண鏍�埍ெகா쿍வ� ப쟍றி த柍க쿍 ��믍ப鏍தா쏍

ம쟍�믍 த柍க쿍 ந迍ப쏍க�டꟍ கலꏍ�ைரயா� அ쯍ல�

ேவ� ஒ� நப�ꟍ ஆேலாசைனய�ꟍ ேப�쯍இꏍத

ஆரா뿍母சிய�쯍 ேச쏍வத쟍埍கான �� உ柍கள�ட믍

ஒꯍபைட埍கꯍப翍�쿍ள�. இ柍� த柍க�埍� அள�埍கꯍபட ��

க�� ப翍� ம�鏍�வ ெசய쯍பா翍�ꟍ அ�ꯍபைடய�쯍 எ柍கள�

ஆ뿍வ�쯍 இைணய�믍.

எ柍கள� ஆ뿍வ�쯍 த柍க쿍 இைணவதாக �� ெச뿍த

ப�ꟍ எ柍கள� ஆரா뿍母சி நிைலய鏍தி쟍� நாꟍ� வார鏍தி쟍�

வார鏍தி쟍� �ꟍ� �ைற வ �த 믍 சிகி母ைச埍காக

அைழ埍கꯍப�வ �쏍, இ母சிகி母ைசயான� ஒퟍெவா� �ைற

சிகி母ைச埍�믍 நா쟍ப� நிமிட믍 ந�柍க쿍 ெசலவ�ட ேவ迍�믍 ,

ஆரா뿍母சி埍காக இ母சிகி母ைச ெதாட柍�믍 ேபா�믍 ��믍

ேபா�믍 த柍க쿍 உட쯍 ெசய쯍திறꟍ ப쟍றிய வ�பர柍கைள ஒ�

ேக쿍வ� ப�வ鏍தி쯍 நிரꯍப� தர ேவ迍�믍.

ேம�믍 ஆரா뿍母சியாள쏍க쿍 த柍க쿍

ஆ뿍வ�ைனவ��믍�믍 ேநர鏍தி쯍 ேம쟍ெகா쿍ள�믍 (இ�

உ柍க쿍 ஆ쏍வ鏍திꟍ அ�ꯍபைடய�쯍 ) ஆ뿍வ�ைன உ柍க쿍

ஒꯍ�த쯍 இꟍறி நி�鏍த�믍 உ�ைம உ쿍ளவ쏍 ஆவ쏍 என

ெத�வ�埍கꯍப�கிற�.

100

ேம�믍 த柍க�埍� சிகி母ைச அள�埍கꯍப翍ட

அ翍டவைணய�ꟍப� ஏேத�믍தவறான எதி쏍பாராத வ�ைள�

ஏ��믍 ஏ쟍ப�믍 என அ母ச믍 ஏ쟍ப翍டா�믍 எꏍதேநர鏍தி�믍

எ柍க쿍 ஆ뿍வ�쯍 இ�ꏍ� தா柍க쿍 வ�லகளா믍 ,இꯍퟍவ�

வ�ல�வதா쯍 எꏍத நꟍைமைய�믍 இழ埍க மா翍�쏍க쿍.

ேம�믍 இꏍத �� க�க ப翍� சிகி母ைச 20 mts அள�埍கꯍபட

இ�ꯍபதா쯍 உ柍க쿍 ேதா쯍 அதிக �迍உண쏍 தꟍைம

ெகா迍டதனா쯍 ேலசான எ�母ச쯍 எ쟍பட��믍 எꟍபைத�믍

ெத�யꯍப�鏍�கிேறꟍ.

நꟍைமக쿍:

1. ��வலி கண�சமாக �ைற�믍.

2. அꟍறாடபண�கள�쯍 �ꟍேன쟍ற믍 ஏ쟍ப�믍

(நட鏍த쯍,�ைவ鏍த쯍,.பல)

3. இꏍத ஆ뿍வ�ꟍ பயꟍ எதி쏍கால ஆ뿍வாள쏍க�埍�

பய�쿍ளதாக அைம�믍.

101

இரகசிய鏍தꟍைம:

த柍கள� ரகசிய தகவ�믍 ம�鏍�வப�ேசாதைன

சா쏍ꏍத தகவ�믍 பா�காꯍபாக ைவ埍கꯍப�믍 எꏍத

ஒ�அ柍கிக�埍காத நப�ட�믍 ெவள�ꯍப�鏍தꯍபட மா翍ட�

எꟍபைத ெத�யꯍப�鏍�கிேறꟍ.

த柍க쿍 ெசாꏍதவ�பர믍, ம�鏍�வேசாதைன��கைள

எ柍க쿍 ஆரா뿍母சியாள쏍க쿍 ம쟍�믍 ஆரா뿍母சி

பய�쏍母சியாள쏍க쿍 ��ம믍 ம翍�ேம அறிꏍ�ெகா쿍வ쏍.

இꏍதிய ம�鏍�வ க翍�ꯍப翍� ��ம믍, ேவ迍�믍 ப翍ச鏍தி쯍

த柍க쿍 வ�பர믍 அள�埍கꯍப�믍 எꟍபைத�믍

ெத�யꯍப�鏍�கிேறꟍ.

ஆ뿍� ��வ�ꟍ தꟍைம அறிவ�ய쯍 இதழி쯍

ப�ர�ரꯍப�鏍தꯍப�믍 அ쯍ல� அꯍேபா� நைடெப�믍

அறிவ�ய쯍 மாநா翍�쯍 கலꏍ�ைறயாடꯍப�믍.

102

இꏍத ஆ뿍வ�ꟍ ��வ�쯍 த柍க쿍 த柍கைள

இைண鏍�ெகாꟍடதா쯍 எꏍத வ�த உதவ� அ쯍ல�

ஊ埍க鏍ெதாைகேயா அள�埍கꯍபடமா翍ட�.

ஆ뿍வ�쯍 ப柍ேக쟍�믍 தꟍனா쏍வல쏍க쿍 ஆ뿍வ�ைன

எꏍத ேநர鏍தி�믍 ெதாட柍கேவா அ쯍ல� வ�லகேவா

��யா� எꟍபைத�믍 ெத�யꯍப�鏍�கிேறꟍ. ேம�믍 உட쯍

உபாைதயா쯍 ஆ뿍வ�쯍 இ�ꏍ� வ�ல�믍 ப翍ச鏍தி쯍

த柍கள�ட믍 இ�ꏍ� எꏍத அபராத ெதாைக�믍 ெபறꯍபடா�

ம쟍�믍 ெகா�埍கꯍபட�믍 மா翍ட� எꟍபைத ெத�வ�鏍�

ெகா쿍கிேறா믍, இதனா쯍 ஆரா뿍சியாள쏍க쿍 உடனான உற�

எퟍவ�த鏍தி�믍 தைடபடா� ப�ꟍ எꯍேபா�

ேவ迍�மானா�믍 சிகி母ைசய�ைன ெதாடரலா믍 என

ெத�யꯍப�鏍�கிேறꟍ.

��ைர:

ந�柍க쿍 ஏேத�믍 இퟍவாரா뿍母சி ��வாக எꏍத

ப�ர母சிைன�믍 அ쯍ல� எதி쏍பாராத உட쯍�தியாக அ쯍ல�

103

உளவ�ய쯍 �தியாக அபய믍, காய믍 அ쯍ல� அசாதாரணமான

ஒ� மா쟍ற믍 நடꯍபதாக நிைன鏍தா쯍 உடன�யாக

ஆரா뿍母சி��வ�쟍� ெத�வ�埍�믍 ப� அறி��鏍தꯍப�கிற�.

இꯍப�埍�

ஆ뿍வ�쯍ேசர வ��ꯍப�쿍ளவ쏍க쿍

ஆரா뿍母சியாள쏍

104

ANNEXURE 3

VISUAL ANALOGUE PAIN SCALE

105

ANNEXURE 4

Revised Oswestry Disability Index (For Low Back Pain/Dysfunction)

Patient name: OP/IP No.: Date:

This questionnaire has been designed to give the doctor information as to how your back pain has affected your ability to manage everyday life. Please answer every section and mark in each section only the ONE box that applies to you. We realize that you may consider that two of the statements in any one section relate to you, but please just mark the box that most closely describes your problem.

SECTION 1-PAIN INTENSITY

o The pain comes and goes and is very mild.

o The pain is mild and does not vary much.

o The pain comes and goes and is moderate.

o The pain is moderate and does not vary much.

o The pain comes and goes and is very severe.

o The pain is severe and does not vary much.

106

SECTION 2-PERSONAL CARE

o I would not have to change my way of washing or dressing in order

to avoid pain.

o I do not normally change my way of washing or dressing even

though it causes some pain.

o Washing and dressing increases the pain, but I manage not to change

my way of doing it.

o Washing and dressing increases the pain and I find it necessary to

change my way of doing it.

o Because of the pain, I am unable to do some washing and dressing

without help.

o Because of the pain, I am unable to do any washing and dressing

without help.

SECTION 3-LIFTING

o I can lift heavy weights without extra pain.

o I can lift heavy weights, but it causes extra pain.

o Pain prevents me from lifting heavy weights off the floor, but I

manage if they are conveniently positioned (e.g., on a table).

o Pain prevents me from lifting heavy weights off the floor.

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o Pain prevents me from lifting heavy weights, but I can manage light

to medium weights if they are conveniently positioned.

o I can only lift very light weights at the most.

SECTION 4-WALKING

o I have no pain on walking.

o I have some pain on walking, but it does not increase with distance.

o I cannot walk more than one mile without increasing pain.

o I cannot walk more than 1/2 mile without increasing pain.

o I cannot walk more than 1/4 mile without increasing pain.

o I cannot walk at all without increasing pain.

SECTION 5-SITTING

o I can sit in any chair as long as I like.

o I can only sit in my favorite chair as long as I like.

o Pain prevents me from sitting more than one hour.

o Pain prevents me from sitting more than 1/2 hour.

o Pain prevents me from sitting more 10 minutes.

o I avoid sitting because it increases pain right away.

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SECTION 6-STANDING

o I can stand as long as I want without pain.

o I have some pain on standing, but it does not increase with time.

o I cannot stand for longer than one hour without increasing pain.

o I cannot stand for longer than 1/2 hour without increasing pain.

o I cannot stand for longer than 10 minutes without increasing pain.

o I avoid standing because it increases the pain right away.

SECTION 7-SLEEPING

o I get no pain in bed.

o I get pain in bed, but it does not prevent me from sleeping well.

o Because of pain, my normal night’s sleep is reduced by less than 1/4.

o Because of pain, my normal night’s sleep is reduced by less than 1/2.

o Because of pain, my normal night’s sleep is reduced by less than 3/4.

o Pain prevents me from sleeping at all.

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SECTION 8-SOCIAL LIFE

o My social life is normal and gives me no pain.

o My social life is normal, but increases the degree of pain.

o Pain has no significant effect on my social life apart from limiting

my more energetic interests, e.g., dancing, etc.

o Pain has restricted my social life and I do not go out very often.

o Pain has restricted my social life to my home.

o I have hardly any social life because of the pain.

SECTION 9-TRAVELLING

o I get no pain while travelling.

o I get some pain while travelling, but none of my usual forms of

travel makes it any worse.

o I get extra pain while travelling, but it does not compel me to seek

alternative forms of travel.

o I get extra pain while travelling, which compels me to seek

alternative forms of travel.

o Pain restricts all forms of travel.

o Pain prevents all forms of travel except that done lying down.

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SECTION 10-CHANGING DEGREE OF PAIN

o My pain is rapidly getting better.

o My pain fluctuates, but is definitively getting better.

o My pain seems to be getting better, but improvement is slow at

present.

o My pain is neither getting better nor worse.

o My pain is gradually worsening.

o My pain is rapidly worsening.

Instructions:

1. This is a self-report questionnaire: the patient is instructed to fill it out.

2. The patient follows the general instructions given at the top of the questionnaire.

3. Each section must be completed. If the patient leaves one blank, instruct them to complete the form. It must be completed in one sitting.

4. Each section has 6 possible answers. Statement 1 is graded as 0 points; statement 6 is graded as 5 points. A total score of 50 is thus possible and would indicate 100% disability. So, for example, a total score of 10 of a possible 50 would constitute a 20% disability.

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5. The following interpretation of disability scores is excerpted from the developers of the Oswestry system (457):

0%-20%: Minimal disability

20%-40% Moderate disability

40%-60%: Severe disability

Pain remains the main problem in this group of patients, but travel, personal care, social life, sexual activity, and sleep are also affected. These patients require detailed investigation.

60%-80%: Crippled

Back pain impinges on all aspects of these patients’ lives both at home and at work and positive intervention is required.

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80%-100%

These patients are either bed-bound or exaggerating their symptoms.

This can be evaluated by careful observation of the patient during medical examination.

6. It is recommended that clinicians focus their discussions of the results with patients in positive terms, rather than reporting disability scores. For example, point out the 10% improvement on a subsequent test.

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