Home » Trials » SLCTR/2022/002
Formulation of evidence-based rehabilitation protocol for anterior shoulder pain: Evaluation of the effectiveness of Myofascial release and Kinesio taping on Bicipital tendinopathy in patients attending the Sports Medicine Clinic, Teaching Hospital Karapitiya.
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SLCTR Registration Number
SLCTR/2022/002
Date of Registration
The date of last modification
Aug 26, 2022
Scientific Title of Trial
Formulation of evidence-based rehabilitation protocol for anterior shoulder pain: Evaluation of the effectiveness of Myofascial release and Kinesio taping on Bicipital tendinopathy in patients attending the Sports Medicine Clinic, Teaching Hospital Karapitiya.
Public Title of Trial
Effectiveness of myofascial release and kinesio taping for pain relief and rehabilitation of bicipital tendinopathy related anterior shoulder complaints.
Disease or Health Condition(s) Studied
Frozen shoulder and bicipital tendinopathy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1258-6595
Any other number(s) assigned to the trial and issuing authority
1.No. 2020.p.126(20.11.2020), Ethical Review Committee, Faculty of Medicine, University of Ruhuna 2.Reg. No. PG/MD/01/2021/73 - Faculty of Graduate Studies, University of Ruhuna
What is the research question being addressed?
How effective are myofascial release and kinesio tape application compared to usual physiotherapy for pain relief and rehabilitation of bicipital tendinopathy related anterior shoulder complaints?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Single
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
1.Study setting: Sports medicine unit of Teaching Hospital Karapitiya 2.Randomization: Simple randomization. Subjects will be randomized into four groups by computer generated random numbering.
Interventions for each of the 3 groups are as follows, Group 1- Only the Myofascial release Group 2- Only the Kinesio taping will be applied Group 3- Both Myofascial release and Kinesio taping will be given Group 4 - Control group These two physiotherapy techniques(interventions) will be delivered by the investigator directly to the subject for 03 times on day 1,5,10, Duration of entire intervention is 14 days
Control: the group receiving electrotherapy and exercise therapy will be the control group Outcome assessors will be blinded, measurements will be taken while both shoulders are fully covered. and both shoulders will be assessed. Outcome assessor will not be the investigator but a different person.
Inclusion criteria
• Both males and females • Age >18 years and < 65 years • A diagnosis of frozen shoulder according to the following criteria, Permanent severe limitation of the range of motion of the shoulder due to inflammation and subsequent scarring around the shoulder joint The classical sign of diagnosing frozen shoulder is the point tenderness of long head of biceps in bicipital groove with the arm at 10° internal rotation among patients complaining anterior shoulder pain.
Exclusion criteria
• Participants who are suspected or diagnosed to be having following conditions around shoulder, Fracture, Malignancy, Cervical radiculopathy, Polymyalgia rheumatica, Bleeding disorders, Acute skin infections • Patients who are currently on any NSAIDs , glucocorticoids or have had shoulder intra articular injections. • Patients who have had any form of myofascial release and or Kinesio taping therapies within past two weeks. • Known skin allergies to adhesive plaster or Kinesio taping • Patients suspected to be having or exposed to COVID 19.
Primary outcome(s)
|
1.
1.Upper limb Disability assessed with DASH (Disability Arm Shoulder Hand Score) 2.Quality of life assessed with WHO QOL BREF (World Health Organization Quality Of Life Brief Questionnaire) 3. Pain assessed with VAS 100 Pain- Visual Analogue Scale |
[ 1.Day 01, Day 05, Day 10, Day 14 2.Day 01, Day 05, Day 10, Day 14 3.Day 01, Day 05, Day 10, Day 14 ] |
Secondary outcome(s)
|
1.
Muscle power and shoulder range of motion using an electrical goniometer and dynamometer, (Model is Microfet 3 Dynamometer and ROM Evaluator) |
[ Day 01, Day 05, Day 10, Day 14 ] |
Target number/sample size
Total 404 (101 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2022-01-14
Anticipated end date
2025-12-31
Date of first enrollment
2022-01-15
Date of study completion
Recruitment status
Recruiting
Funding source
Investigator funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-02-17
Approval number
No. 2020.p.126(20.11.2020),
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine University of Ruhuna |
| Institutional Address: | Faculty of Medicine University of Ruhuna, Karapitiya, Galle ,Sri Lanka |
| Telephone: | 0912234801/803 Ext: 161 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Yakupiti Himan Shashindra De Silva
Medical officer
Sports medicine unit,
Teaching Hospital Karapitiya, Sri Lanka
0912232250
+94777555681
drhiman1975@gmail.com
http://sportmedicinegallelk.org/en/
Contact Person for Public Queries
Sampath Gunawardana
Professor in Physiology
Department of Physiology
Faculty of Medicine
University of Ruhuna
091-224-6871
071-416-0258
sampathgu@yahoo.com
Primary study sponsor/organization
Yakupiti Himan Shashindra De Silva
Medical officer
Sports medicine unit
Teaching Hospital Karapitiya, Sri Lanka
+94777555681
drhiman1975@gmail.com
http://sportmedicinegallelk.org/en/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
