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

NCT05948995 | Completed DMC

• 1 other identifier: 022/2566
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Arthroscopic Rotator Cuff Repair

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change of visual analog scale for pain from baseline

  Change from visual analog scale after 6 weeks postoperative

• Change of constant Murley's score from baseline

  Change from visual analog scale after 6 weeks postoperative

• Change of the Thai version of the Shoulder Pain and Disability Index from baseline

  Change from visual analog scale after 6 weeks postoperative

Study Arms (2)

Conventional arm sling

NO INTERVENTION

Conventional arm sling Arm position : Internal rotation , Adduction

Abduction external rotational brace

EXPERIMENTAL

Abduction external rotational brace Arm position : Abduction , External rotation

Device: Abduction external rotation brace

Interventions

Abduction external rotation brace DEVICE

Abduction external rotation brace Arm position : Abduction , External rotation

Also known as: Arm sling with abduction pillow

Abduction external rotational brace

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with full thickness rotator cuff tear
• Plan for arthroscopic rotator cuff repair

You may not qualify if:

• Revision cuff surgery
• Unable to answer question
• Previous shoulder surgery
• Full thickness subscapularis tear

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, Si Racha, 20110, Thailand

Location

Study Officials

• Chuenrutai Yeekian, Ph.D.

  QSMVH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: On the follow up date , both groups will be removed sling / brace before receiving by outcome assessor
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 17, 2023
• Study Start: July 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)