- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05331963
Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
The Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
Study Overview
Detailed Description
Subacromial impingement is a condition among athletes those involved in overhead sports activities such as swimming and volleyball. According to Neer there are two main categories of shoulder impingement, these are structural and functional. Structural: caused by reduction of the subacromial space (SAS) due to bony growth, calcification or soft tissue inflammation whereas functional is caused by or superior migration of the humeral head due to muscular weakness imbalance. In some cases subacromial impingement can be result from a combination of both structural and functional factors.Maintenance of the SAS during arm elevation is thus essential for the prevention of Rotator cuff tendinopathy.
The aim of this randomized controlled trial (RCT) is to evaluate the long-term effects of scapular KT, added to a 6-week rehabilitation program, on the subacromial space at different arm positions in athletes with Rotator cuff tendinopathy. To better understand the underlying mechanisms of KT, our secondary objective addressed the effects of KT on reliving pain-free and full ROM of shoulder joint.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Federal
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Islamabad, Federal, Pakistan, 44000
- Pain and Spine Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 to 35 years
- Both gender
- Athletes participating in volley ball, tennis, badminton and golf.
- Presence of shoulder pain in abduction and external rotation during training for more than three months
- Three out of five positive results for the following: painful arc, pain or weakness with resisted external rotation, abduction, Neer test, Hawkins Kennedy test, empty can test/Jobe test
Exclusion Criteria:
- H/O shoulder fractures,
- Instability or dislocation (positive apprehension and relocation tests)
- Frozen shoulder (All stages)
- Recent shoulder surgery for a shoulder injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Kinesio taping with rehabilitation program group
Rehabilitation program will be given to this group in addition to Kinesio taping on skin for 72 hour.
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Kinesio tape is designed in a specific way that it mimics the human skin nature.
It more or less has the same width as the epidermis layer and can be stretched upto 40% of its resting length.Clinically, kinesio tape (KT) is used both alone and with other physiotherapeutic interventions, mainly for the pain control, to reduce inflammation, and to improve functional activity in patients with shoulder pain
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No Intervention: Rehabilitation plan group
The rehabilitation program will be provided individually to all participants (twice weekly during the first 4 weeks, then once weekly)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subacrimial space measurement by Ultrasonography
Time Frame: Six weeks
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In order to visualize and measure the subacromial space, the Diagnostic Ultrasound will be used with Aquasonic ultrasound gel as the coupling medium.
An ultrasound scanner (Canon aplio i600) with frequency of 1 to 22 MHz curved probe will be used in this study to get images.
The probe of US will be placed on the anterior-lateral surface of the acromion process, next to the longitudinal axis of the humeral head, and this is the point likely to view the acromion process and humeral head at the same time.
The AHD will then measured from inferior surface of acromion process to the superior surface of the humeral head.The distance is basically from cortical layers of both acromion and humerus bone.
The acromio humeral distance will be measured at resting position (0° elevation) of shoulder in millimeters.
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Six weeks
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Visual Analogue Scale
Time Frame: Six weeks
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This scale consist of 0 to 10 rating in which 0 indicates no pain, and 10 indicates the worst pain.(9)
The score of VAS is determined by measuring the distance between the no pain or 0 anchor and to the point where patient draw a mark.
A higher score indicates greater pain intensity.
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Six weeks
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The Disabilities of Arm, Shoulder and Hand Questionnaire
Time Frame: Six weeks
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The DASH will be used to measure functional disorder, physical disability and symptoms of the upper limbs.
It consists of 30 questions.
21 questions are related to specific physical tasks in which a person felt difficulty performing last week.
6 questions are to assess specific symptoms including pain, numbness and stiffness.
3 questions are about social and occupational limitations.
A 100 point score signifies the most severe disability.
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Six weeks
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The Western Ontario Rotator Cuff Index
Time Frame: Six weeks
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This instrument consists of 21 items with 5 further categories: i) 6 items of Physical symptoms,ii) 4 items of sports and recreation functions, iii) 4 items of work functions, iv) 4items of lifestyle functions and v) emotional function with 3 items.
The instrument has clear instructions to the patients in addition to the explanation of each item of every category.
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Six weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aadil Omer, Ph.D., Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01022 Hajra Qureshi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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