- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06070493
The Effects of Myofascial Release Technique
March 5, 2024 updated by: Tuğçe Çoban, Gazi University
The Effects of Myofascial Release Technique in Patients With Rotator Cuff Injury: A Single-Blind Randomized Controlled Trial
This study was planned to investigate the long-term effects of myofascial release technique on proprioception, pain severity, shoulder range of motion, functional level, flexibility, and muscle strength in patients with rotator cuff injury.
The study included 29 individuals with partial rotator cuff injury who were randomly divided into two groups.
The control group received a classical physiotherapy program including transcutaneous electrical nerve stimulation, hot pack and exercise, while the treatment group received the same classic physiotherapy program along with the myofascial release technique.
All treatments were planned for 4 weeks and a total of 10 sessions.
Proprioception, pain severity, shoulder range of motion, functional level, flexibility and muscle strength were assessed before and after the treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Rotator cuff injury is the most common cause of shoulder pain and dysfunction in adults.
It may cause muscle weakness, changes in glenohumeral kinematics, and instability in the shoulder internal and external rotator muscle groups and abductors.
Patients may present a variety of symptoms, ranging from painless to severe shoulder pain and from normal function to severe dysfunction.
It causes a decrease in the level of function in individuals, limitation in daily living activities, decreased quality of life and sleep problems.
Various psychological factors, such as emotional or mental collapse and fear-avoidance behaviors, have been found to be associated with severe pain and disability in these patients.
In response to emotional or physical injuries and traumas, fascia shortens, thickens, and stiffens.
This situation causes pain and dysfunction.
Conservative treatment is primarily preferred in the treatment of rotator cuff injury.
In cases where there is no response to conservative treatment, surgery is used.
Conservative treatment includes patient education, electrophysical agents, and exercise program.
The exercise program includes scapular stabilization exercises, rotator cuff and shoulder area muscle strengthening exercises, range of motion exercises and stretching exercises.
Additionally, the use of manual therapy techniques increases the effect of the treatment.
Myofascial release technique, one of the manual therapy techniques, is a widely used therapy that involves low load and long-term mechanical forces to manipulate the myofascial complex, aiming to restore optimal length, reduce pain and improve function.
With the myofascial release technique, proprioception is also increased.
Considering the possible changes in the fascia, it is thought that the myofascial release technique may be useful in the conservative treatment program of individuals with rotator cuff injury.
When the literature is examined, there is no study examining the effect of myofascial release technique on individuals with rotator cuff injury.
The aim of this study is to investigate the long-term effects of myofascial release technique on proprioception, pain severity, shoulder range of motion, functional level, flexibility, and muscle strength in patients with rotator cuff injury.
Study Type
Interventional
Enrollment (Actual)
44
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
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06490
- Gazi 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The diagnosis of partial rotator cuff rupture
- Being between 18-65 years of age
Exclusion Criteria:
- Shoulder joint surgery
- Local steroid injection to the shoulder within the last 3 months
- Physiotherapy and rehabilitation within the last 3 months
- Cervical discopathy
- Severe shoulder osteoarthritis
- Upper extremity fracture or tumor
- Frozen shoulder
- Shoulder instability
- Thoracic outlet syndrome
- Neurological and mental problems
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control group
classical physiotherapy
|
For individuals of control group, a hot pack was applied to the shoulder area for 15 minutes, while the individuals were in the sitting position.
The conventional mode of transcutaneous electrical nerve stimulation was used.
Frequency was adjusted in the range of 50-100 Hz, and the amplitude intensity was adjusted between 10-30 milliampere with the intensity of mild tingling without causing any excessive discomfort or contractions.
Electrodes were placed at the anterior, posterior, superior, and inferior of the shoulder region.
In the exercise program of the patients, joint range of motion exercises, stretching, scapular stabilization, rotator cuff, and shoulder muscle strengthening exercises were given.
|
Experimental: Treatment group
classical physiotherapy and myofascial release
|
For individuals of control group, a hot pack was applied to the shoulder area for 15 minutes, while the individuals were in the sitting position.
The conventional mode of transcutaneous electrical nerve stimulation was used.
Frequency was adjusted in the range of 50-100 Hz, and the amplitude intensity was adjusted between 10-30 milliampere with the intensity of mild tingling without causing any excessive discomfort or contractions.
Electrodes were placed at the anterior, posterior, superior, and inferior of the shoulder region.
In the exercise program of the patients, joint range of motion exercises, stretching, scapular stabilization, rotator cuff, and shoulder muscle strengthening exercises were given.
myofascial release technique was applied to the patients in the treatment group besides the control group program.
The technique was applied to the lateral neck and shoulder, pectoral region, scapulothoracic area, and arm regions for 5 minutes for optimum benefit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proprioception
Time Frame: Baseline
|
Proprioception is the joint position sense.
Shoulder flexion, abduction and external rotation proprioception were measured with a digital inclinometer.
Deviations between the targeted angle and the angle performed by the patients were noted.
|
Baseline
|
Proprioception
Time Frame: After four weeks of treatment
|
Proprioception is the joint position sense.
Shoulder flexion, abduction and external rotation proprioception were measured with a digital inclinometer.
Deviations between the targeted angle and the angle performed by the patients were noted.
|
After four weeks of treatment
|
Pain severity
Time Frame: Baseline
|
Pain is an unpleasant sensation and emotional experience.
The severity of pain at rest and during activity was evaluated using visual analog scale.
The starting point of the line indicated "no pain" and the end point "unbearable pain" using a 10 cm horizontal line.
|
Baseline
|
Pain severity
Time Frame: After four weeks of treatment
|
Pain is an unpleasant sensation and emotional experience.
The severity of pain at rest and during activity was evaluated using visual analog scale.
The starting point of the line indicated "no pain" and the end point "unbearable pain" using a 10 cm horizontal line.
|
After four weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion
Time Frame: Baseline
|
Range of motion is the measurement of movement.
Active shoulder flexion, abduction, and internal and external rotation range of motion measurements were performed bilaterally with a universal goniometer in the supine position.
|
Baseline
|
Range of motion
Time Frame: After four weeks of treatment
|
Range of motion is the measurement of movement.
Active shoulder flexion, abduction, and internal and external rotation range of motion measurements were performed bilaterally with a universal goniometer in the supine position.
|
After four weeks of treatment
|
Functional level
Time Frame: Baseline
|
Functional level was assessed by Shoulder Pain and Disability Index (SPADI).
SPADI consists of a total of 13 items, 5 of which determine the level of pain and 8 items that determine the level of disability.
|
Baseline
|
Functional level
Time Frame: After four weeks of treatment
|
Functional level was assessed by Shoulder Pain and Disability Index (SPADI).
SPADI consists of a total of 13 items, 5 of which determine the level of pain and 8 items that determine the level of disability.
|
After four weeks of treatment
|
Flexibility
Time Frame: Baseline
|
The ability to move muscles and joints through a full normal range of motion.
Flexibility of the internal and external rotator muscles of the shoulder was measured with the patient in the sitting position.
The measurement was made by recording the distance between the middle fingers of both hands with a tape measure.
|
Baseline
|
Flexibility
Time Frame: After four weeks of treatment
|
The ability to move muscles and joints through a full normal range of motion.
Flexibility of the internal and external rotator muscles of the shoulder was measured with the patient in the sitting position.
The measurement was made by recording the distance between the middle fingers of both hands with a tape measure.
|
After four weeks of treatment
|
Muscle strength
Time Frame: Baseline
|
Shoulder flexor, abductor, and internal and external rotator muscle strength were measured bilaterally using a digital hand dynamometer.
Measurements were made with the patient in the sitting position.
For all measurements, patients were asked to respond to the resistance for 3 seconds.
All of the procedures were repeated 3 times and 1 minute rest was given between sets.
|
Baseline
|
Muscle strength
Time Frame: After four weeks of treatment
|
Shoulder flexor, abductor, and internal and external rotator muscle strength were measured bilaterally using a digital hand dynamometer.
Measurements were made with the patient in the sitting position.
For all measurements, patients were asked to respond to the resistance for 3 seconds.
All of the procedures were repeated 3 times and 1 minute rest was given between sets.
|
After four weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zeynep Hazar, PhD, Gazi 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
- Nho SJ, Yadav H, Shindle MK, Macgillivray JD. Rotator cuff degeneration: etiology and pathogenesis. Am J Sports Med. 2008 May;36(5):987-93. doi: 10.1177/0363546508317344. Epub 2008 Apr 15.
- Celik MS, Sonmezer E, Acar M. Effectiveness of proprioceptive neuromuscular facilitation and myofascial release techniques in patients with subacromial impingement syndrome. Somatosens Mot Res. 2022 Jun-Dec;39(2-4):97-105. doi: 10.1080/08990220.2021.2018293. Epub 2022 Jan 7.
- Gunes M, Yana M. Acute effects of thoracolumbar fascia release techniques on range of motion, proprioception, and muscular endurance in healthy young adults. J Bodyw Mov Ther. 2023 Jul;35:145-150. doi: 10.1016/j.jbmt.2023.04.063. Epub 2023 Apr 20.
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)
September 19, 2022
Primary Completion (Actual)
May 15, 2023
Study Completion (Actual)
June 1, 2023
Study Registration Dates
First Submitted
September 19, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-302.08.01-407339
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.
Clinical Trials on Rotator Cuff Injuries
-
The Cleveland ClinicRecruitingRotator Cuff Tears | Rotator Cuff RepairsUnited States
-
Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Xiros LtdNot yet recruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the Shoulder
-
Spital Thurgau AGRecruiting
-
CONMED CorporationRecruitingRotator Cuff TearsUnited States
-
The University of Texas Health Science Center,...Skye BiologicsNot yet recruiting
-
Peking University Third HospitalRecruiting
-
Kaohsiung Veterans General Hospital.Recruiting
-
University of CalgaryRecruiting
-
Seoul National University Bundang HospitalMinistry of Health, Republic of KoreaRecruitingRotator Cuff TearsKorea, Republic of
Clinical Trials on classic physiotherapy program
-
Ugur CavlakBiruni UniversityCompletedLow Back Pain, MechanicalTurkey
-
Pamukkale UniversityCompletedRotator Cuff TearsTurkey
-
Eastern Mediterranean UniversityCompletedQuality of Life | Physical Activity | Metabolic Syndrome
-
European University of LefkeCompleted
-
University Hospital, MontpellierRecruiting
-
Azusa Pacific UniversityWithdrawnAnxiety Disorders | Stress Disorders, Traumatic | AnxietyUnited States
-
Eastern Mediterranean UniversityUnknownLumbar Disc HerniationCyprus
-
University of MalagaCompletedMuscular Dystrophy, Duchenne and Becker TypesSpain
-
Hacettepe UniversityUnknown
-
Nigde Omer Halisdemir UniversityCompleted