The Effects of Myofascial Release Technique
Primary Purpose
Rotator Cuff Injuries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
classic physiotherapy program
Myofascial release
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring Myofascial Release Therapy, Proprioception, Shoulder Pain, Rotator Cuff Lesions
Eligibility Criteria
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
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
Treatment group
Arm Description
classical physiotherapy
classical physiotherapy and myofascial release
Outcomes
Primary Outcome Measures
Proprioception
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.
Proprioception
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.
Pain severity
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.
Pain severity
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.
Secondary Outcome Measures
Range of motion
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.
Range of motion
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.
Functional level
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.
Functional level
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.
Flexibility
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.
Flexibility
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.
Muscle strength
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.
Muscle strength
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06070493
Brief Title
The Effects of Myofascial Release Technique
Official Title
The Effects of Myofascial Release Technique in Patients With Rotator Cuff Injury: A Single-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
Keywords
Myofascial Release Therapy, Proprioception, Shoulder Pain, Rotator Cuff Lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
classical physiotherapy
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
classical physiotherapy and myofascial release
Intervention Type
Other
Intervention Name(s)
classic physiotherapy program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proprioception
Description
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.
Time Frame
Baseline
Title
Proprioception
Description
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.
Time Frame
After four weeks of treatment
Title
Pain severity
Description
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.
Time Frame
Baseline
Title
Pain severity
Description
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.
Time Frame
After four weeks of treatment
Secondary Outcome Measure Information:
Title
Range of motion
Description
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.
Time Frame
Baseline
Title
Range of motion
Description
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.
Time Frame
After four weeks of treatment
Title
Functional level
Description
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.
Time Frame
Baseline
Title
Functional level
Description
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.
Time Frame
After four weeks of treatment
Title
Flexibility
Description
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.
Time Frame
Baseline
Title
Flexibility
Description
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.
Time Frame
After four weeks of treatment
Title
Muscle strength
Description
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.
Time Frame
Baseline
Title
Muscle strength
Description
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.
Time Frame
After four weeks of treatment
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Hazar, PhD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06490
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18413681
Citation
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.
Results Reference
background
PubMed Identifier
34991428
Citation
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.
Results Reference
background
PubMed Identifier
37330761
Citation
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.
Results Reference
background
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The Effects of Myofascial Release Technique
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