Do Convolutions in Kinesio Taping Matter?

eAddenda

Do convolutions in Kinesio Taping matter? A comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial

Patrícia do Carmo Silva Parreira1, Luciola da Cunha Menezes Costa1,2, Ricardo Takahashi3, Luiz Carlos Hespanhol Junior1, Tatiane Motta Silva1, Maurício Antônio da Luz Junior1 and Leonardo Oliveira Pena Costa1,2

1Universidade Cidade de São Paulo, Brazil, 2Musculoskeletal Division – The George Institute for Global Health, Australia, 3Private Physiotherapist, Brazil

Journal of Physiotherapy Vol 59 No 1 p 52

Complete protocol

©Copyright Australian Physiotherapy Association 2013

of 12 Introduction Chronic low back pain is a very prevalent condition (Hoy et al 2012) which is associated with disability and imposes an enormous economic burden to the society (Dagenais et al 2008). Patients with chronic low back pain usually experience improvements in the first six weeks after the onset of chronicity but then very small reductions in pain and disability are observed between six weeks and one year (Costa et al 2012). Therefore, due to this unfavourable prognosis, a large number of patients with chronic low back pain seek care for their symptoms. There is a wide variety of treatment options for chronic low back that are endorsed by clinical practice guidelines (Airaksinen et al 2006, Delitto et al 2012), however the magnitude of the effects of these interventions are, at best, small to moderate (Airaksinen et al 2006). A new method of treatment that is very popular in sports physiotherapy is the Kinesio Taping Method. This intervention has been recommended for patients with low back pain and is based upon the use of specific elastic tapes (known as Kinesio Tex Gold®) that should be applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position (Kase et al 2003). The Kinesio Tex tape has been designed to allow for a longitudinal stretch up to 140% of its resting length. The combination of the stretching capacity of the Kinesio Tex Gold® tape with the muscle in a stretched position will create convolutions as the skin is lifted. According to the treatment manual, these convolutions would aid blood and lymphatic flow as well as reduce pain in patients with musculoskeletal conditions (Kase et al 2003). The Kinesio Taping Method Manual states that ‘the proper tension application is one of the most critical factors in the application´s success’ (Kase et al 2003 p.14). However, the theory that the amount of tension is important has never been tested in a large, high quality randomised controlled trial in patients with chronic low back pain. Therefore the research questions of this study are: 1. Is the application of Kinesio Taping according to the treatment manual (ie, generating convolutions in the skin by applying the Kinesio Tape with a tension of 10–15%) more efficacious than a simple application (ie, not generating convolutions in the skin by applying the Kinesio Tape without any tension) with the treated muscles in resting position in patients with chronic low back pain? 2. Can the effects observed after 4 weeks of treatment be sustained over 3 months after randomisation?

of 12 Method

Design This will be an assessor-blinded, two-arm randomised controlled trial (Figure 1) that is funded by the Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP), and by the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil. Measurements will be taken at baseline, immediately following the intervention (4 weeks) as well as at 3 months after randomisation to examine maintenance of any intervention effects. The study protocol has been approved by the Universidade Cidade de São Paulo Research Ethics Committee (research protocol number PP13603502) and has been prospectively registered in the Brazilian Registry of Clinical Trials (Registration number: RBR-7ggfkv).

Figure 1: Flow diagram of the study.

of 12 Participants, therapists, centres We will recruit patients presenting with low back pain of at least three months’ duration, aged between 18 and 80 years, of both genders, who are seeking treatment for low back pain. Patients with any contraindication to physical exercise (ACSM 1995) according to the guidelines of the American College of Sports Medicine; patients with serious spinal pathology (including fractures, tumours and inflammatory diseases); nerve root compromise; serious cardiopulmonary conditions; pregnancy; and patients with any contraindications to the use of taping (such as skin allergy or intolerance to the tape material) will be excluded from the study. Patients will be treated by three physiotherapists who were trained to deliver the Kinesio Taping Method interventions by two certified Kinesio Taping Method practitioners. These practitioners will audit the interventions whenever necessary. Each patient will be treated by the same physiotherapist, who will not be involved in patient assessment. The trial will be conducted in two outpatient physiotherapy clinics in the cities of São Paulo and Campo Limpo Paulista, Brazil.

Intervention/control A total of 148 patients will be randomly allocated to receive two different approaches of Kinesio Taping Method application: 3. Experimental group – who will be taped with a I-Shape Kinesio Tex Gold® Tape over the erector spinae muscle with 10–15% of tension (paper-off tension) with the treated muscles in stretching position and having convolutions in neutral according to the Kenzo Kase’s Kinesio Taping Method Manual (Kase et al 2003); and 4. Control group – who will be taped with a I-Shape Kinesio® Tex Tape over the erector spinae muscle without tension (no convolutions in neutral) with the treated muscle in resting position. The treatments in both groups will be delivered during 4 weeks (8 treatment sessions, twice a week, with three days interval between the sessions). During the study period, patients could normally use the medications prescribed by their clinician. The use of any analgesics or anti- inflammatory drugs will be monitored during the treatment sessions. All patients will be orientated not to seek care or other type of treatment for their low back pain and they will be allowed to maintain their regular activities, which will be also monitored during the treatment sessions. Prior to the randomisation, patients will receive a patch test to rule out any allergic

of 12 reaction. Patients will retain this patch for 24 hours, and if they do not have any allergic reactions they will be randomised into one of the treatment groups. The Kinesio Taping Method uses elastic bandages that are attached in the patient´s skin over the area to be treated. These bandages (Kinesio Tex Gold®) are comprised of polymer elastic strand wrapped by 100% (Kase et al 2003) cotton fibers without latex (hypoallergenic). The tape is waterproof, porous, with a thickness similar to the epidermis of the skin; it is adhesive, being made of 100% acrylic which is activated by heat (Kase et al 2003). The elastic bandage has been designed to stretch only in the longitudinal direction (which can be applied in different cuts and curves) and may stretch up to 140% of its resting length, this elasticity being similar to the elastic qualities of the human skin. The Kinesio Tex Gold ® Tape is manufactured with approximately 10–15% of the available tension applied to the paper substrate; its elastic qualities are effective for 3–5 days (Kase et al 2003). Several bandage application techniques can be used in patients with low back pain, such as ‘star’, ‘H’, ‘Y’, ‘X’ and ‘I’ techniques. In this study the tape will be applied using the’I’- Shaped Kinesio Tex Gold® tape over the erector spinae muscle (bilaterally) parallel to the spinous processes of the lumbar vertebrae (Figure 2). The reference points for taping will be the posterior superior iliac spine and the T8 vertebrae. The experimental group will be taped with I-Shaped Kinesio Tex Gold® tape over the erector spinae muscle with 10–15% of tension (paper-off tension) with the treated muscles in stretching position and having convolutions in neutral according to the Kenzo Kase’s Kinesio Taping Method Manual. The procedure begins by placing the distal base of the Kinesio Tex strip approximately 2 inches (5 cm) below the posterior superior iliac spine without tension – therefore, the therapist should remove the tape from the paper backing in only the amount required to begin the base application. Subsequently, for each ‘I’ strip application, the patient will be asked to move the lumbar spine into flexion to position the erector spinae muscle in a stretched position, as recommended by the manual (Kase et al 2003). Then the tape should be applied over the skin with light tension (10–15% of available tension and creating convolutions in neutral), which is also known as ‘paper-off’ tension. Once the distal base application is completed, the therapist should tear the paper backing just below the base of the ‘I’ strip, leaving the paper backing on the strip. As the ‘I’ strip is applied in the skin, the tape is removed from the paper substrate using the ‘paper off’ tension (ie, 10–15% of available tension and creating convolutions in neutral). Consequently, the tape application finishes by placing the proximal base of the Kinesio Tex strip approximately 2 inches (5 cm) above the vertebra T8 with 0%

of 12 of tension and then the therapist should rub the Kinesio Tex Gold Tape to initiate the glue adhesion (Figure 3).

Figure 2a 2b 2c

Figure 2. I-Shape Kinesio Tex® Tape over the Erector Spinae muscle with 10–15% of tension (paper- off tension) with the treated muscles in stretching position according to the Kenzo Kase’s Kinesio taping manual.

The control group will be taped with an I-Shape Kinesio Tex Gold® tape over the erector spinae muscle with no tension (no convolutions in neutral) and with the treated muscle in resting position. The procedure begins by placing the distal base of the Kinesio Tex strip approximately 2 inches (5 cm) below the posterior superior iliac spine without tension (no convolutions in neutral), therefore, the therapist should remove the tape from the paper backing in only the amount required to begin the base application. Subsequently, for each ‘I’ strip application, the patient will be asked to remain in standing position to keep the erector spinae muscle in a non-stretched position. Then the tape should be applied over the skin without tension (no convolutions in neutral). To apply the Kinesio Tex tape without tension, the therapist should peel the remaining paper backing away (keeping only the paper backing on the proximal base) to release the 10–15% of available tension that is applied to the tape during manufacturing, bringing the tape to 0% of tension (no convolutions in neutral). Once the therapist has removed the paper backing from the ‘I’ strip, the therapist should attach the tape in the skin lightly. Consequently, the tape application finishes by placing the proximal base of the Kinesio Tex Tape approximately 2 inches (5 cm) above the T8 vertebra without convolutions in neutral then the therapist should rub the Kinesio Tex Tape to initiate the glue adhesion.

of 12 Figure 3a 3b 3c

Figure 3. I-Shape Kinesio Tex® Tape over the erector spinae muscle with no tension (0% tension) and with the treated muscle in a non-stretched position.

Prior to the tape application in both groups the skin will be cleaned with 70% alcohol to improve the tape adherence, as the skin should be free of oils and lotions. Patients will remain taped for two consecutive days and after this period patients will be instructed to remove the tape, clean and treat the skin with a lotion moisturizer. The patients will remain without the tape for 24 hours to allow for the skin to recover properly for the subsequent tape application. Patients will be asked if the bandage is limiting lumbar movement and in these cases, the Kinesio Tape will be reapplied so that they have unrestricted range of motion. After this period, patients will return to the physiotherapy clinic and a new tape will be applied. This process will be repeated for 4 weeks. There is no guarantee that the tape tension will be maintained throughout the period of 48 hours, however it is not expected that the tension will be reduced to 0%, unless the patient removes the tape early.

Outcome measures A total of three outcome measures will be used: 1) Pain Numerical Rating Scale (NRS) to determine the intensity of pain; 2) Roland Morris disability Questionnaire (RMDQ) (Roland and Morris 1983) for the assessment of disability associated with back pain; and 3) Global Perceived Effect Scale (GPE) (Fischer et al 1999) to evaluate the global impression of recovery. The NRS, RMDQ and GPE have been properly translated, cross-culturally adapted into Portuguese, and tested for their measurement properties in patients with low back pain in Brazil (Costa et al 2008, Costa et al 2007, Nusbaum et al 2001). Their measurement properties are acceptable and equivalent to the original English version. We will also record

of 12 any type of adverse effects that might occur (such as allergic reactions or skin problems, for example).

Primary outcomes The primary outcomes will be pain intensity and disability associated with low back pain measured immediately after treatment (4 weeks).

Secondary outcomes The secondary outcomes will be pain intensity and disability associated with low back pain measured 3 months after randomisation and global impression of recovery measured immediately after treatment (4 weeks) and 3 months after randomisation.

A detailed description of each of these outcome measures is presented as follows.

Pain Numerical Rating Scale. Pain intensity will be measured by the Brazilian-Portuguese version of the 11-point Pain Numerical Rating Scale (Costa et al 2008). The pain NRS ranges from 0 to 10, where 0 represents ‘no pain’ and 10 represents ‘worst possible pain’. The participants will be asked to rate their levels of pain intensity based upon the last seven days. This outcome will be measured at all time-points (ie, baseline, 4 weeks, and 3 months after randomisation). Roland Morris Disability Questionnaire. The Roland Morris Disability Questionnaire is an instrument that is used widely in research and clinical practice for measuring disability associated with low back pain (Roland and Morris 1983). This questionnaire contains 24 items related to daily activities that the patients may have difficulty performing due to low back pain. The greater the number of items selected, the greater the disability. Participants will be instructed to check the items that in fact describe them on the day of the assessment. This outcome will be measured at all time-points (ie, baseline, 4 weeks, and 3 months after randomization). Global Perceived Effect Scale. The Global Perceived Effect Scale is an 11-point scale ranging from –5 (‘vastly worse’), through 0 (no change) to +5 (completely recovered) (Fischer et al 1999). For all measures of global perceived effect (at baseline and in all follow- ups), participants will be asked: ‘Compared to when this episode first started, how would you describe your low back these days?’ A higher positive score indicates greater recovery and negative scores indicate worsening of the symptoms. This outcome will be measured at all time-points (ie, baseline, 4 weeks, and 3 months after randomisation).

of 12 Procedure We will recruit patients with chronic low back pain (with symptoms of at least 3 months’ duration) who will be seeking care for their problem, as well as from the community. Patients will be screened by a physiotherapist who will be unaware of treatment allocation in order to confirm eligibility. This screening involves taking a careful medical history and a physical examination. Eligible patients will be informed about the study objectives and procedures and if they agree to participate in the study, they will sign a consent form. The physiotherapist will then collect baseline data and will perform an allergy test in all patients. This allergy test consists of applying a small Kinesio Tex Gold patch over the skin. Patients will keep this patch on for 24 hours and will be instructed to remove the patch and call the chief investigators if any allergic reaction occurs. Eligible patients without allergic reaction to the patch test will be booked for the randomisation and first treatment session. The randomisation schedule was computer-generated by the chief investigator who will not be involved in the recruitment or treatment of the patients. The allocation of subjects will be concealed using numbered, sequentially ordered, sealed opaque envelopes. The envelopes will be opened sequentially by the treating physiotherapists who will immediately provide the first session of treatment to the patients. Clinical outcomes (pain intensity, disability, and global impression of recovery) will be obtained in assessments that will be performed by a blinded assessor at 4 weeks and 3 months after randomisation. Patients will be informed that they will receive one of two different forms of Kinesio Taping application, therefore they cannot be considered as blinded. Due to the nature of the interventions it will not be possible to blind the therapists. This randomised controlled trial started recruitment in 1 April 2012 and the anticipated date of completion is February 2013.

Data analysis The analysis will be conducted by a statistician who will receive coded data. The effects of the interventions for both primary and secondary outcomes will be calculated using Linear Mixed Models. We will not perform secondary or subgroup analysis. The Statistical Package for Social Sciences (SPSS) 19 will be used for the analysis. The sample size calculation for this study was based to detect a between-group difference of 1 point for pain intensity measured by the Portuguese version of the Pain Numerical Rating Scale (with an estimated standard deviation of 1.84 points), and 4 points for disability measured by the Roland Morris Disability Questionnaire (estimated standard deviation of 4.9

of 12 points) with a statistical power of 80%, an alpha of 5%, and a possible loss to follow up of 15% across all time points. Therefore 74 patients per group (148 in total) will be needed. Discussion The results of this study will contribute to a better understanding of the real importance of convolutions in neutral for the effectiveness of Kinesio Taping method in patients with chronic low back pain. As the evidence of the efficacy/effectiveness of this intervention is still very limited (Castro-Sanchez et al 2012, Paoloni et al 2011), the results of this large, high-quality randomised controlled trial may help physiotherapists on their clinical decision- making process. This study has an adequate sample size to detect a clinical relevant treatment effect with low risk of bias. In terms of pragmatism, this trial was designed to reproduce the intervention exactly as is currently recommended by the treatment manual as well by certified Kinesio Taping Method instructors, which enhances the clinical relevance of the trial results. Previous studies have not directly investigated the importance of the presence or absence of convolutions, but according to the creators of the method, the success of therapy depends largely on the presence of these convolutions. There is a possibility that the participants allocated to the control group may still momentarily generate convolutions in their taping if they move into a hyper-extension posture, but this stimulus is generated only on this movement (as opposed to the patients from the intervention group who will generate convolutions most of the time), therefore the likely benefits of convolutions will be much smaller in the control group participants compared to the intervention group. A very similar trial with low risk of bias was published recently (Castro-Sanchez et al 2012) but with some important differences when compared to our study. First, the dosage used in the previous published trial was much smaller than the one that will be used in our study (ie, 1 tape over a week versus 8 tapes over 4 weeks). Second, the authors of the previous study observed the treatment effects at 7 days and 5 weeks after randomisation, while our study time-points will be 4 and 12 weeks after randomisation. Third, our trial has a much larger sample (n = 148), compared to the existing trial (n = 60). Finally, we do not consider our 0% tension group as a placebo (Hancock et al 2006, Machado et al 2008), as it is unlikely that any tape applied over the skin would be inert in terms of pain due to the gate control theory. Therefore the conclusions from our trial can add important information on the existing evidence of the use of Kinesio Taping Method in patients with chronic low back pain. Human research ethics approval: Universidade Cidade de São Paulo Research Ethics Committee, # PP13603502.

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