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

Arthroscopic Rotator Cuff Repair Clinical Trial

— ARCR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948995
• Other study ID #: 022/2566
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: Thada Wipatasinlapin, MD
• Phone: 0909095599
• Email: fighter.thada[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Rotator Cuff Repair

Intervention

Device:
• Abduction external rotation brace
Abduction external rotation brace Arm position : Abduction , External rotation

Locations

Country	Name	City	State
Thailand	Queen Savang Vadhana Memorial Hospital	Chon Buri	Si Racha

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of range of motion of shoulders from baseline	Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)	At postoperative 3 weeks
Primary	Change of range of motion of shoulders from baseline	Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)	At postoperative 6 weeks
Primary	Change of range of motion of shoulders from baseline	Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)	At postoperative 3 months
Primary	Change of range of motion of shoulders from baseline	Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)	At postoperative 6 months
Primary	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	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
Secondary	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
Secondary	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