Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff

Study Overview
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Brief Summary
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Comparison between Abduction External Rotation Brace and Arm Sling after Arthroscopic Rotator Cuff : A Randomized Controlled Trial Comparison of primary outcome : range of motion (at pre-operative , post-operative) , pain score , shoulder functional score

Detailed Description
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Comparison between Abduction External Rotation Brace and Arm Sling after Arthroscopic Rotator Cuff : A Randomized Controlled Trial Comparison of primary outcome : range of motion (at pre-operative , post-operative) , pain score , shoulder functional score There are gaps of knowledge which sling/brace are the best for post operative arthroscopic rotator cuff repair Because patient who underwent arthroscopic rotator cuff repair have to wear these sling/brace for at least 1 month after operation , the better one could reduce post-operative shoulder stiffness , decrease pain and improve functional shoulder score

Official Title
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Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff : A Randomized Controlled Trial

Conditions
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Arthroscopic Rotator Cuff Repair

Intervention / Treatment
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* Device: Abduction external rotation brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with full thickness rotator cuff tear Plan for arthroscopic rotator cuff repair Exclusion Criteria: Revision cuff surgery Unable to answer question Previous shoulder surgery Full thickness subscapularis tear

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The participants were randomly divided into two groups. The control group received arm sling post operative arthroscopic rotator cuff repair. The experimental group received abduction external rotation brace post operative arthroscopic rotator cuff repair.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional arm sling<br>Conventional arm sling Arm position : Internal rotation , Adduction | |
| Experimental: Abduction external rotational brace<br>Abduction external rotational brace Arm position : Abduction , External rotation | Device: Abduction external rotation brace<br>* Abduction external rotation brace Arm position : Abduction , External rotation<br>* Other names: Arm sling with abduction pillow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of range of motion of shoulders from baseline | Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation) | At postoperative 3 weeks | 
| Change of range of motion of shoulders from baseline | Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation) | At postoperative 6 weeks | 
| Change of range of motion of shoulders from baseline | Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation) | At postoperative 3 months | 
| Change of range of motion of shoulders from baseline | Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation) | At postoperative 6 months | 
| Change of range of motion of shoulder from baseline | Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation) | At postoperative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of visual analog scale for pain from baseline | Range from 1-10 (1 = minimum pain, 10 = maximum pain) | Change from visual analog scale after 6 weeks postoperative | 
| Change of constant Murley's score from baseline | Score 0-100 (Functional shoulder score), 0 = worst, 100 = best | Change from visual analog scale after 6 weeks postoperative | 
| Change of the Thai version of the Shoulder Pain and Disability Index from baseline | Thai functional shoulder score 0 = worst, 100 = best | Change from visual analog scale after 6 weeks postoperative |