Rotator Cuff TearsNCT05064774
The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs
A study testing myofascial release technique and physiotherapy in people with Rotator Cuff Tears, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
this study was conducted the patients with rotator cuff tears who underwent rotator cuff repair surger.The patients were randomly divided into 2 groups and a total of 20 subjects were randomized in a single block order using RandomAllocation Software 1.0.0 by simple randomization.All evaluation and treatment was done… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- myofascial release technique and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 1 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged betweeen 18-65
- diagnosed with RC tear
Who cannot join
- wanting to leave the study
- not participating in assessments and/or treatments
- presence of massive tears
- accompanying nerve injuries,
- presence of labral lesion,
- diagnosed psychological problems,
Show all 9Show fewer
- central nervous system problems
- those with any rheumatological and orthopedic diseases
- individuals who have had previous surgery on the same shoulder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20070
About this study
Official title: The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs: A Randomized Controlled Pilot Study
this study was conducted the patients with rotator cuff tears who underwent rotator cuff repair surger.The patients were randomly divided into 2 groups and a total of 20 subjects were randomized in a single block order using RandomAllocation Software 1.0.0 by simple randomization.All evaluation and treatment was done by the same physiotherapist.The first group was included in the traditional treatment program after rotator cuff repair, while the second group was included in the myofascial release program, 2 sessions a week between the 4th and 7th weeks, in addition to the traditional treatment.
Read the detailed description
Patients in the 2 groups undergoing rc repair were also included in a similar physiotherapy program.Immobilization with a sling was made for 4-6 weeks after surgery. In addition to physiotherapy in group 2, myofascial release therapy was applied to the upper trapezius, sternocloidomastoideus, pectoral muscles (major, minor) 2 days a week between the 4th and 7th weeks after surgery, in addition to the conventional treatment. Myofascial treatment took 30-45 minutes per session.
- Conditions
- Rotator Cuff Tears
- Being tested
- myofascial release technique, physiotherapy
- Keywords
- myofascial release, rotator cuff tears, physiotherapy, rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial release techniqueOther
myofascial release group took myofascial release (MFR) therapy sessions twice a week for 4 weeks between 4 and 7 weeks. MFR was applied to upper trapezius, SCM, pectoralis major-minor and sternocostal fascia. muscle was replaced elongated position and pressure was applied for 60-120 second.
physiotherapyOther
Also called classic physiotherapy
patients used sling up to 4 weeks. They did first 4 weeks passive/ assistive range of motion exercise. In 6-8 weeks they did active exercises. 8-12 weeks they did progressive resistive exercises.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Patients who underwent arthroscopic rotator cuff repair surgery (n=10). They were implemented physiotherapy after the surgery once a week for 12 weeks. They were encouraged to do exercises 3 to 5 times every day. Receives: Other: physiotherapy |
| myofascial release group | Experimental | Patients who underwent arthroscopic rotator cuff repair surgery (n=10). They were implemented physiotherapy the same as the control group once a week for 12 weeks. In addition to physiotherapy they took myofascial release sessions twice a week for 4 weeks between 4 and 7 weeks. Receives: Other: myofascial release technique; Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
visual analog scale (pain during night, rest, activity), preoperative, post operative 3-7-12 weeks.
Measured: 12 weeks
function
Constant Murley's score. This score has been used in preoperative, post operative 7-12 weeks. Higher score means better results. total point changes between 0-100.
Measured: 12 weeks
quality of life ındex
short form-36 (SF-36) This scale is used in preoperative and pos operative 12 weeks.Higher score means better results.
Measured: 12 weeks
Secondary outcomes (2)
grip strength
Grip strength has been measured with dynamometer in preoperative, post operative 7-12 weeks.
Measured: 12 weeks
flexibility
pectoralis minor flexibility was measured and saved as centimeter.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Aug 2018
- Primary completion20 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Pamukkale 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 controlled study this study was conducted with rotator cuff tear patients who underwent arthroscopic rotator cuff treatment. The patients' pain intensity, joint range of motion, flexibility of shoulder muscles, grip and muscle strength, shoulder function evaluations and physical characteristics, age, differences between body mass index were evaluated with Mann Whitney-U test.Measurements before and after treatment were evaluated with the Wilcoxon test. Friedman test was performed for the measurements made at postoperative 3, 7, and 12 weeks before in-group treatment. Bonferoni correction was done for possible differences.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyye Cildan Uysal, Pamukkale University
- Investigators
- Sumeyye CILDAN UYSAL, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064774
- Sponsor's protocol ID
- 60116787-020/41785
- Status last verified
- May 2023
- First submitted
- 22 Sep 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
PubMed 21655457LeBauer A, Brtalik R, Stowe K. The effect of myofascial release (MFR) on an adult with idiopathic scoliosis. J Bodyw Mov Ther. 2008 Oct;12(4):356-63. doi: 10.1016/j.jbmt.2008.03.008. Epub 2008 Jun 4.
PubMed 19083694Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
PubMed 5054450
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05064774
- Acronym / sponsor ID
- 60116787-020/41785
- Conditions
- Rotator Cuff Tears
- Keywords
- myofascial release, rotator cuff tears, physiotherapy, rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 1 Oct 2021 (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.
this study was conducted the patients with rotator cuff tears who underwent rotator cuff repair surger.The patients were randomly divided into 2 groups and a total of 20 subjects were randomized in a single block order using RandomAllocation Software 1.0.0 by simple randomization.All evaluation and treatment was done by the same physiotherapist.The first group was included in the traditional treatment program after rotator cuff repair, while the second group was included in the myofascial release program, 2 sessions a week between the 4th and 7th weeks, in addition to the traditional treatment.
Detailed description
Patients in the 2 groups undergoing rc repair were also included in a similar physiotherapy program.Immobilization with a sling was made for 4-6 weeks after surgery. In addition to physiotherapy in group 2, myofascial release therapy was applied to the upper trapezius, sternocloidomastoideus, pectoral muscles (major, minor) 2 days a week between the 4th and 7th weeks after surgery, in addition to the conventional treatment. Myofascial treatment took 30-45 minutes per session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised controlled study this study was conducted with rotator cuff tear patients who underwent arthroscopic rotator cuff treatment. The patients' pain intensity, joint range of motion, flexibility of shoulder muscles, grip and muscle strength, shoulder function evaluations and physical characteristics, age, differences between body mass index were evaluated with Mann Whitney-U test.Measurements before and after treatment were evaluated with the Wilcoxon test. Friedman test was performed for the measurements made at postoperative 3, 7, and 12 weeks before in-group treatment. Bonferoni correction was done for possible differences.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: physiotherapyPatients who underwent arthroscopic rotator cuff repair surgery (n=10). They were implemented physiotherapy after the surgery once a week for 12 weeks. They were encouraged to do exercises 3 to 5 times every day. |
| myofascial release group | Experimental | Other: myofascial release technique, Other: physiotherapyPatients who underwent arthroscopic rotator cuff repair surgery (n=10). They were implemented physiotherapy the same as the control group once a week for 12 weeks. In addition to physiotherapy they took myofascial release sessions twice a week for 4 weeks between 4 and 7 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged betweeen 18-65
- diagnosed with RC tear
Key exclusion criteria (9 listed)
- wanting to leave the study
- not participating in assessments and/or treatments
- presence of massive tears
- accompanying nerve injuries,
- presence of labral lesion,
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 |
|---|---|---|
| myofascial release techniquemyofascial release group took myofascial release (MFR) therapy sessions twice a week for 4 weeks between 4 and 7 weeks. MFR was applied to upper trapezius, SCM, pectoralis major-minor and sternocostal fascia. muscle was replaced elongated position and pressure was applied for 60-120 second. | Other | myofascial release group |
| physiotherapyAlso: classic physiotherapypatients used sling up to 4 weeks. They did first 4 weeks passive/ assistive range of motion exercise. In 6-8 weeks they did active exercises. 8-12 weeks they did progressive resistive exercises. | Other | control group, myofascial release group |
Primary outcome
pain intensity
Time frame: 12 weeks
visual analog scale (pain during night, rest, activity), preoperative, post operative 3-7-12 weeks.
function
Time frame: 12 weeks
Constant Murley's score. This score has been used in preoperative, post operative 7-12 weeks. Higher score means better results. total point changes between 0-100.
quality of life ındex
Time frame: 12 weeks
short form-36 (SF-36) This scale is used in preoperative and pos operative 12 weeks.Higher score means better results.
2 secondary outcomes
grip strength
Time frame: 12 weeks
flexibility
Time frame: 12 weeks
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 24 May 2023.
- Background: PubMed 21655457Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
- Background: PubMed 19083694LeBauer A, Brtalik R, Stowe K. The effect of myofascial release (MFR) on an adult with idiopathic scoliosis. J Bodyw Mov Ther. 2008 Oct;12(4):356-63. doi: 10.1016/j.jbmt.2008.03.008. Epub 2008 Jun 4.
- Background: PubMed 5054450Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.
- 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.
Sumeyye CILDAN UYSAL principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial release technique and physiotherapy in people with Rotator Cuff Tears, run by Pamukkale 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 2 inclusion and 9 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 24 May 2023. 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?
pain intensity (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT05064774, which also lists 3 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 24 May 2023.