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

January 28, 2025 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Si Racha
      • Chon Buri, Si Racha, Thailand, 20110
        • Queen Savang Vadhana Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional arm sling
Conventional arm sling Arm position : Internal rotation , Adduction
Experimental: Abduction external rotational brace
Abduction external rotational brace Arm position : Abduction , External rotation
Device: Abduction external rotation brace
Abduction external rotation brace Arm position : Abduction , External rotation
Other Names:
  • Arm sling with abduction pillow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of range of motion of shoulders from baseline
Time Frame: At postoperative 3 weeks
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
At postoperative 3 weeks
Change of range of motion of shoulders from baseline
Time Frame: At postoperative 6 weeks
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
At postoperative 6 weeks
Change of range of motion of shoulders from baseline
Time Frame: At postoperative 3 months
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
At postoperative 3 months
Change of range of motion of shoulders from baseline
Time Frame: At postoperative 6 months
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
At postoperative 6 months
Change of range of motion of shoulder from baseline
Time Frame: At postoperative 1 year
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
Time Frame: Change from visual analog scale after 6 weeks postoperative
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
Time Frame: Change from visual analog scale after 6 weeks postoperative
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
Time Frame: Change from visual analog scale after 6 weeks postoperative
Thai functional shoulder score 0 = worst, 100 = best
Change from visual analog scale after 6 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

  • Study Chair: Chuenrutai Yeekian, Ph.D., QSMVH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 022/2566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data was save in form of microsoft excel spreadsheet and SPSS file

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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