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

10 Jan 2022

The date of last modification

Jan 10, 2022



Application Summary


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


Trial Details


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

2021-01-14


Anticipated end date

2025-12-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Investigator funded


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)

None





Trial Completion details


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