Rotator Cuff TearNCT03533088
Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair
A study testing Hospitalized rehabilitation and Home-based rehabilitation in people with Rotator Cuff Tear, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Hospitalized rehabilitation and Home-based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2019to 15 Feb 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a Rotator Cuff repair surgery
- Having post-op rehabilitation program at our clinic until post-op 3 months
- No previous surgery in the shoulder joint
Who cannot join
- Additional pathology other then RC tear
- Refusing to participate to the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation
Altındağ, Ankara, 06600
About this study
Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore, rehabilitation after the RC repair procedure is crucial for the success of the treatment. However, there is no concencus between the post-operative rehabilitation protochol. The aim of this study is to compare two different rehabilitation protochols on patients with RC repair.
Read the detailed description
Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore, rehabilitation after the RC repair procedure is crucial for the success of the treatment. However, there is no concencus between the post-operative rehabilitation protochol. The aim of this study is to compare two different rehabilitation protochols in terms of shoulder range of motion, self-reported shoulder function and pain on patients with RC repair.
- Conditions
- Rotator Cuff Tear
- Being tested
- Hospitalized rehabilitation, Home-based rehabilitation
- Keywords
- shoulder, rotator cuff, exercise
- Medical subject headings
- Rotator Cuff Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalized rehabilitationOther
Patients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks
Home-based rehabilitationOther
Patients will recive a home program once in a two weeks until the 6. weeks of post-operative period. Then will start to recieve a rehabilitation program ar the clinic once in a week auntil the 12. week of the post-operative period.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized rehabilitation | Experimental | Patients in this group will recieve rehabilitation program twice in a week at our clinic after the surgical procedure until post-operative 12 weeks. Receives: Other: Hospitalized rehabilitation |
| Home-based rehabilitation | Experimental | Patients in his groups will performed home-based rehabilitation in the early stages of the post-op period. They will com to our clinic once in a two weeks and the recieve the exercise program to perform at home until the 6. weeks of the post-operative period. After the 6. week they will come to our clinic once in a week until the post-operative 12. week. Receives: Other: Home-based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
scapular kinematics
3-Dimensional scapular kinematics will be assessed
Measured: 6 months
Secondary outcomes (1)
gleno-humeral range of motion
patients' shoulder range of motions will be assessed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start15 Jul 2019
- Primary completion30 Sep 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Randomised control trial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Duzgun, Hacettepe University
- Investigators
- Taha Yıdız, Msc, Study chair, İnvestigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533088
- Sponsor's protocol ID
- 1233412334
- Status last verified
- Aug 2021
- First submitted
- 10 May 2018
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallagher BP, Bishop ME, Tjoumakaris FP, Freedman KB. Early versus delayed rehabilitation following arthroscopic rotator cuff repair: A systematic review. Phys Sportsmed. 2015 May;43(2):178-87. doi: 10.1080/00913847.2015.1025683. Epub 2015 Mar 22.
PubMed 25797067Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the rotator cuff: a systematic review. Physiotherapy. 2016 Mar;102(1):20-8. doi: 10.1016/j.physio.2015.08.003. Epub 2015 Sep 8.
PubMed 26510584
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT03533088
- Acronym / sponsor ID
- 1233412334
- Conditions
- Rotator Cuff Tear
- Keywords
- shoulder, rotator cuff, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 22 May 2018 (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.
Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore, rehabilitation after the RC repair procedure is crucial for the success of the treatment. However, there is no concencus between the post-operative rehabilitation protochol. The aim of this study is to compare two different rehabilitation protochols on patients with RC repair.
Detailed description
Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore, rehabilitation after the RC repair procedure is crucial for the success of the treatment. However, there is no concencus between the post-operative rehabilitation protochol. The aim of this study is to compare two different rehabilitation protochols in terms of shoulder range of motion, self-reported shoulder function and pain on patients with RC repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Hospitalized rehabilitation | Experimental | Other: Hospitalized rehabilitationPatients in this group will recieve rehabilitation program twice in a week at our clinic after the surgical procedure until post-operative 12 weeks. |
| Home-based rehabilitation | Experimental | Other: Home-based rehabilitationPatients in his groups will performed home-based rehabilitation in the early stages of the post-op period. They will com to our clinic once in a two weeks and the recieve the exercise program to perform at home until the 6. weeks of the post-operative period. After the 6. week they will come to our clinic once in a week until the post-operative 12. week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a Rotator Cuff repair surgery
- Having post-op rehabilitation program at our clinic until post-op 3 months
- No previous surgery in the shoulder joint
Key exclusion criteria (2 listed)
- Additional pathology other then RC tear
- Refusing to participate to the study
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 |
|---|---|---|
| Hospitalized rehabilitationPatients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks | Other | Hospitalized rehabilitation |
| Home-based rehabilitationPatients will recive a home program once in a two weeks until the 6. weeks of post-operative period. Then will start to recieve a rehabilitation program ar the clinic once in a week auntil the 12. week of the post-operative period. | Other | Home-based rehabilitation |
Primary outcome
scapular kinematics
Time frame: 6 months
3-Dimensional scapular kinematics will be assessed
1 secondary outcome
gleno-humeral range of motion
Time frame: 6 months
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 25 Aug 2021.
- Results publication: PubMed 25797067Gallagher BP, Bishop ME, Tjoumakaris FP, Freedman KB. Early versus delayed rehabilitation following arthroscopic rotator cuff repair: A systematic review. Phys Sportsmed. 2015 May;43(2):178-87. doi: 10.1080/00913847.2015.1025683. Epub 2015 Mar 22.
- Results publication: PubMed 26510584Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the rotator cuff: a systematic review. Physiotherapy. 2016 Mar;102(1):20-8. doi: 10.1016/j.physio.2015.08.003. Epub 2015 Sep 8.
- Individual participant dataSharing planned: No
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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.
Taha Yıdız, Msc study chair
İnvestigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospitalized rehabilitation and Home-based rehabilitation in people with Rotator Cuff Tear, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 25 Aug 2021. 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 Turkey (Türkiye). 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?
scapular kinematics (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533088, which also lists 2 linked publications.
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 25 Aug 2021.