Arthroscopic Rotator Cuff RepairARCRNCT05948995
Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff
A study testing Abduction external rotation brace in people with Arthroscopic Rotator Cuff Repair, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroscopic Rotator Cuff Repair
- What is being tested?
- Abduction external rotation brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with full thickness rotator cuff tear
- Plan for arthroscopic rotator cuff repair
Who cannot join
- Revision cuff surgery
- Unable to answer question
- Previous shoulder surgery
- Full thickness subscapularis tear
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Savang Vadhana Memorial Hospital
Chon Buri, Si Racha, 20110
About this study
Official title: 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
Read the 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
- Conditions
- Arthroscopic Rotator Cuff Repair
- Being tested
- Abduction external rotation brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abduction external rotation braceDevice
Also called Arm sling with abduction pillow
Abduction external rotation brace Arm position : Abduction , External rotation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Abduction external rotation brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of range of motion of shoulders from baseline
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
Measured: At postoperative 3 weeks
Change of range of motion of shoulders from baseline
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
Measured: At postoperative 6 weeks
Change of range of motion of shoulders from baseline
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
Measured: At postoperative 3 months
Change of range of motion of shoulders from baseline
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
Measured: At postoperative 6 months
Change of range of motion of shoulder from baseline
Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)
Measured: At postoperative 1 year
Secondary outcomes (3)
Change of visual analog scale for pain from baseline
Range from 1-10 (1 = minimum pain, 10 = maximum pain)
Measured: Change from visual analog scale after 6 weeks postoperative
Change of constant Murley's score from baseline
Score 0-100 (Functional shoulder score), 0 = worst, 100 = best
Measured: Change from visual analog scale after 6 weeks postoperative
Change of the Thai version of the Shoulder Pain and Disability Index from baseline
Thai functional shoulder score 0 = worst, 100 = best
Measured: Change from visual analog scale after 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jul 2022
- Primary completion1 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Rotator Cuff RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chuenrutai Yeekian, Ph.D., Study chair, QSMVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948995
- Sponsor's protocol ID
- 022/2566
- Acronym
- ARCR
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data was save in form of microsoft excel spreadsheet and SPSS file
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05948995
- Acronym / sponsor ID
- ARCR / 022/2566
- Conditions
- Arthroscopic Rotator Cuff Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional arm sling | No intervention | –Conventional arm sling Arm position : Internal rotation , Adduction |
| Abduction external rotational brace | Experimental | Device: Abduction external rotation braceAbduction external rotational brace Arm position : Abduction , External rotation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with full thickness rotator cuff tear
- Plan for arthroscopic rotator cuff repair
Key exclusion criteria (4 listed)
- Revision cuff surgery
- Unable to answer question
- Previous shoulder surgery
- Full thickness subscapularis tear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abduction external rotation braceAlso: Arm sling with abduction pillowAbduction external rotation brace Arm position : Abduction , External rotation | Device | Abduction external rotational brace |
Primary outcome
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)
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)
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)
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)
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)
3 secondary outcomes
Change of visual analog scale for pain from baseline
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No. Data was save in form of microsoft excel spreadsheet and SPSS file
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuenrutai Yeekian, Ph.D. study chair
QSMVH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abduction external rotation brace in people with Arthroscopic Rotator Cuff Repair, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of range of motion of shoulders from baseline (time frame: At postoperative 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.