NCT05064774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

September 22, 2021

Last Update Submit

May 22, 2023

Conditions

Keywords

myofascial releaserotator cuff tearsphysiotherapyrotator cuff repair

Outcome Measures

Primary Outcomes (3)

  • pain intensity

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

    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.

    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.

    12 weeks

Secondary Outcomes (2)

  • grip strength

    12 weeks

  • flexibility

    12 weeks

Study Arms (2)

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.

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.

Other: myofascial release techniqueOther: physiotherapy

Interventions

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.

myofascial release group

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.

Also known as: classic physiotherapy
control groupmyofascial release group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged betweeen 18-65
  • diagnosed with RC tear

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

Related Publications (3)

  • Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.

    PMID: 21655457BACKGROUND
  • 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.

    PMID: 19083694BACKGROUND
  • 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.

    PMID: 5054450BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Myofascial Release TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsRehabilitation

Study Officials

  • Sumeyye CILDAN UYSAL

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 1, 2021

Study Start

August 1, 2018

Primary Completion

March 20, 2021

Study Completion

April 1, 2021

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations