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Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 19:49:21 GMT)

CTRI Number CTRI/2016/04/006828 [Registered on: 18/04/2016] - Trial Registered Retrospectively Last Modified On 24/07/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Physiotherapy (Not Including YOGA) Other (Specify) [Dry Needling and Intramuscular Electrical Stimulation] Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Effects of dryneedling and intramuscular electrical stimulation on shoulder pain and dysfunction Scientific Title of Effects Of Trigger Points Dry Needling With and Without Intramuscular Electrical Stimulation On Study Improving Shoulder Function In Non-Traumatic Shoulder Pain and Dysfunction Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Sukumar S Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation Nitte Institute of Physiotherapy Address Nitte Institute of Physiotherapy, Nitte University, Deralakatte, Department of Physiotherapy, Justice.K.S.Hegde Charitable Hospital, Medical Science Complex, Deralakatte, Mangalore Dakshina 575018 Phone 0824-2202443 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Sukumar S Query) Designation Assistant Professor Affiliation Nitte Institute of Physiotherapy Address Nitte Institute of Physiotherapy, Nitte University, Deralakatte, Mangalore Justice K S Hegde Charitable Hospital, Medical Science Complex, Deralakatte, Mangalore KARNATAKA 575018 India Phone 2202443 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Lawrence Mathias Designation Professor Affiliation K S Hegde Medical Academy Address K S Hegde Medical Academy Nitte University, Nithyananda Nagar, Deralakatte, Mangalore Department of Orthopaedics, Justice K S Hegde Charitable Hospital, Medical Science Complex, Deralakatte, Mangalore

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Dakshina Kannada KARNATAKA 575018 India Phone 0824-2202443 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Nitte University, 6th floor, Medical Science Complex, Deralakatte, Mangalore Primary Sponsor Primary Sponsor Details Name Nitte University Address 6th Floor, Medical Science Complex, Deralakatte, Mangalore, Karnataka, India. Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Sukumar S Nitte Institute of Department of 9482254497 Physiotherapy, Nitte Physiotherapy, Room University, Justice K S Number: 20, Justice K [email protected] Hegde Charitable S Hegde Charitable Hospital Hospital, Deralakatte, Mangalore - 575 018. Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Central Ethics Approved 14/06/2014 No Committee, Nitte University Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Non-Traumatic Shoulder Pain and Dysfunction Intervention / Type Name Details Comparator Agent Intervention Intramuscular Electrical Intramuscular Electrical Stimulation Stimulation with Dry Needle is a new Intervention Technique used to deactivate Myofascial Trigger Points in the skeletal muscles. Low Frequency Electrical Current is applied Intramuscularly over the Myofascial Trigger Points for 2-3 minutes Twice in a week for Three Weeks. 48-72 Hours Interval between the Two sessions.Tt may produce Widespread Electrically induced

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Muscle Relaxation and Improving Movement Function. Comparator Agent Classical Trigger Point Dry Classical Dry Needling is a Needling Minimally Invasive Trigger Point Deactivation Technique Mainly Used in Myofascial Pain Syndrome. A Thin Solid Sterilised (o.25 mm Thick)is Inserted Intramuscularly into the Myofascial Trigger Points and Will Be Removed after few minutes. This is performed 2 days In A Week for Three Weeks. Inclusion Criteria Inclusion Criteria Age From 30.00 Year(s) Age To 60.00 Year(s) Gender Both Details presense of myofascial trigger points in shoulder girdle muscles due to non-traumatic shoulder pain and dysfunction Exclusion Criteria Exclusion Criteria Details history of recent fracture of upper limb bones diabetic neuropathies hemiplegia/ hemiparesis hemophilia needle phobia, needle allergy immune system disorders and etc...

Method of Generating Stratified block randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints Shoulder Pain Pain Intensity Assessed using Visual Analog Upper Limb Function Scale, Upper Limb Function Assessed using Shoulder Range of Motion Disability of Arm, Shoulder and Hand Questionnaire and Shoulder Range of Motion Assessed using Universal Goniometer. All Outcome Variables Assessed over the Period of Three Months Secondary Outcome Outcome Timepoints Shoulder Pain Pre Intervention Assessment on Day 1 and Post Upper Limb Function Intervention Assessment At The End of Each Shoulder Range of Motion Weeks for Three Consecutive Weeks carried out. Follow-up Assessment was Performed after Three Months Post Intervention Period. Target Sample Size Total Sample Size=266 Sample Size from India=266 Final Enrollment numbers achieved (Total)=230 Final Enrollment numbers achieved (India)=230 Phase of Trial Phase 2 Date of First 18/02/2014 Enrollment (India) Date of First No Date Specified

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Enrollment (Global) Estimated Duration of Years=2 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details 1. Sukumar S, Lawrence Matthias. "Effects of intramuscular manual therapy (dry needling) on improving shoulder abduction range of movement in unilateral adhesive capsulitis"- single blinded randomized control study. Global journal of multidisciplinary studies. November 2014; 3(12):41-50. 2. Shanmugam S, Mathias L, Thakur A, Kumar D. Effects of inversely electrodes placed intramuscular electrical stimulation on myofascial syndrome of shoulder: a case series. Korean Journal of Pain. 2014;29(2): ahead of print. 3. Sukumar S, Kavitha Shetty, Lawrence Mathias. Dry Needling Effects on Non-Specific Cervical Radiculopathic Pain and Dysfunction:-A Case Report. Int J Ther Rehab Res 2015; 4 (4): 21-25 4. Shanmugam S, Shetty K, Mathias L, Santhumayor R. Dry needling on tendons and myofascial trigger points in post-traumatic stiffness of elbow: a case report. Int J Res Med Sci 2015; 3:1529-32. Brief Summary this is the first rct in intramuscular electrical stimulation on myofascial trigger points deactivation in non traumatic shoulder pain and dysfunction. after the ethical approval from the nitte university central ethics committee we have done the pilot study in 30 subjects in the phase one of our study. and the results were reported and submitted to nitte university. now we are in the second stage of our study and this study results will give better treatment option for those who are suffering from various shoulder disorders.

research team: Sukumar S, principal investigator, assistant professor, nitte institute of phsiotherapy

RESEARCH GUIDE: PROF.(DR.) LAWRENCE MATHIAS, ORTHOPAEDIC SURGEON, KSHEMA

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