- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064774
The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs
May 22, 2023 updated by: Sumeyye Cildan Uysal, Pamukkale University
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
20
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
-
-
Pamukkale
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Denizli, Pamukkale, Turkey, 20070
- Pamukkale University
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- aged betweeen 18-65
- diagnosed with RC tear
Exclusion Criteria:
- 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,
- central nervous system problems
- those with any rheumatological and orthopedic diseases
- individuals who have had previous surgery on the same shoulder
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
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.
|
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.
Other Names:
|
|
Experimental: myofascial release group
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.
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: 12 weeks
|
visual analog scale (pain during night, rest, activity), preoperative, post operative 3-7-12 weeks.
|
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.
|
12 weeks
|
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
grip strength
Time Frame: 12 weeks
|
Grip strength has been measured with dynamometer in preoperative, post operative 7-12 weeks.
|
12 weeks
|
|
flexibility
Time Frame: 12 weeks
|
pectoralis minor flexibility was measured and saved as centimeter.
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sumeyye CILDAN UYSAL, Pamukkale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
- Neer 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.
- LeBauer 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.
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)
August 1, 2018
Primary Completion (Actual)
March 20, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
September 22, 2021
First Submitted That Met QC Criteria
September 22, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/41785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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