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Completed

NCT Number: NCT05948995

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

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

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Key information

Conditions

Arthroscopic Rotator Cuff Repair

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Savang Vadhana Memorial Hospital

Chon Buri, Si Racha, 20110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abduction external rotation brace

Device

Abduction external rotation brace Arm position : Abduction , External rotation

Other names: Arm sling with abduction pillow

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

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

Acronym: ARCR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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