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

Not Applicable

Completed

• Conditions: Arthroscopic Rotator Cuff Repair
• Interventions: Device: Abduction external rotation brace

• Registration Number: NCT05948995
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Brief Summary

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

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

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-17
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Abduction external rotational brace	Abduction external rotation brace	Abduction external rotational brace Arm position : Abduction , External rotation

Primary Outcome Measures

Name	Time	Method
Change of range of motion of shoulders from baseline	At postoperative 6 months	Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
Change of range of motion of shoulder from baseline	At postoperative 1 year	Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Savang Vadhana Memorial Hospital; 🇹🇭 Chon Buri, Si Racha, Thailand