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The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
myofascial release technique
physiotherapy
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring myofascial release, rotator cuff tears, physiotherapy, rotator cuff repair

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of massive tears
  • accompanying nerve injuries,
  • presence of labral lesion,
  • diagnosed psychological problems,
  • central nervous system problems
  • those with any rheumatologicaland orthopedic diseases
  • individuals who have had previous surgery on the same shoulder

Exclusion Criteria:

  • wanting to leave the study
  • not participating in assessments and/or treatments

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

myofascial release group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

pain intensity
visual analog scale (pain during night, rest, activity), preoperative, post operative 3-7-12 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.
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.

Secondary Outcome Measures

grip strength
Grip strength has been measured with dynamometer in preoperative, post operative 7-12 weeks.
flexibility
pectoralis minor flexibility was measured and saved as centimeter.

Full Information

First Posted
September 22, 2021
Last Updated
May 22, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05064774
Brief Title
The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs
Official Title
The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs: A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
myofascial release, rotator cuff tears, physiotherapy, rotator cuff repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
myofascial release group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
myofascial release technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
physiotherapy
Other Intervention Name(s)
classic physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain intensity
Description
visual analog scale (pain during night, rest, activity), preoperative, post operative 3-7-12 weeks.
Time Frame
12 weeks
Title
function
Description
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.
Time Frame
12 weeks
Title
quality of life ındex
Description
short form-36 (SF-36) This scale is used in preoperative and pos operative 12 weeks.Higher score means better results.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
grip strength
Description
Grip strength has been measured with dynamometer in preoperative, post operative 7-12 weeks.
Time Frame
12 weeks
Title
flexibility
Description
pectoralis minor flexibility was measured and saved as centimeter.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumeyye CILDAN UYSAL
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21655457
Citation
Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
Results Reference
background
PubMed Identifier
19083694
Citation
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.
Results Reference
background
PubMed Identifier
5054450
Citation
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.
Results Reference
background

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The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs

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