- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756167
Effect of Myofascial Relaxation on Individuals With Adhesive Capsulitis
The Effect of Myofascial Relaxation on Pain, Functionality and Quality of Life in Individuals With Adhesive Capsulitis: A Randomized Controlled Single-Blind Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adhesive capsulitis is a shoulder pathology characterized by pain persisting for more than three months due to fibrosis and contractures in the glenohumeral joint capsule, active and passive joint motion limitation and functional insufficiency. Although there are many factors that trigger this pathology, also known as frozen shoulder, its etiology is not known precisely. The clinical findings, course and prognosis are known with the researches. Although its incidence in the general population is %2-5, it is more likely to be seen in women between the ages of 40-70 and more than men. There are two types, primary and secondary. Primary frozen shoulder is idiopathic. Secondary frozen shoulder develops secondary to trauma, immobilization, rotator cuff tears, diabetes, biceps tendinitis, myocardial infarction, cerebrovascular event, psychological disorders, and post-surgical causes. Soft tissue contracture and adhesions in the capsule and axillary space are also seen in the pathogenesis. It is examined clinically in three stages. The first phase lasts about 0-3 months, when the intensity of the pain is high and the limitation of shoulder movements begins gradually. In the second stage, the severity of the pain slightly decreases, but the limitation of joint motion gradually increases, functionality decreases and lasts for about 3-9 months. In the third stage, the severity of the pain decreases, the joint movement limitations begin to recover slowly and gradually and lasts about 9-15 months. The treatment program shaped according to the characteristics of the stages; It includes conservative treatment approaches consisting of patient education, prevention, medical treatment, physiotherapy and exercises, and may require surgical treatment depending on the severity of the prognosis. Patient education in conservative treatment, hot packs, Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), Laser, Iontophoresis etc. Electrotherapy agents, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, taping, joint and soft tissue mobilizations, manual therapy techniques and therapeutic exercises such as stretching exercises, range of motion exercises, proprioceptive neuromuscular facilitation techniques are frequently used.
Restriction in shoulder movements is quite evident especially in flexion, abduction and external rotation movements. Contracture of the ligaments in the shoulder reduces the volume of the capsule. The capsule decreasing in volume causes limitation of movement. However, the pain is not only due to the tension in the capsular and ligaments, but also due to the tension in the muscles and fascia and trigger toxins. Many therapeutic methods are used to relieve these trigger points and facial tensions. One of these methods is the "myofascial release technique" that focuses on soft tissues that are particularly tense and in spasm. This technique is a treatment method aimed at resolving fascial adhesions, restoring the optimal length of the muscle, reducing pain and increasing functionality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kağıthane
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Istanbul, Kağıthane, Turkey, 34394
- Private Levent Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being diagnosed with adhesive capsulitis
- Being 18 years or older
- Agree to voluntarily participate in research
Exclusion Criteria:
- Cervical disc hernias
- Neuromuscular diseases
- Full thickness rotator cuff tears
- Shoulder impingement syndrome
- Individuals with corticosteroid injection into the shoulder joint
- Individuals who have undergone surgical procedures on the shoulder joint
- Individuals with bone tumors or other malignant diseases
- Having mental and cognitive problems
- Physiotherapy or manual therapy on the same shoulder 6 months ago
Study Plan
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 |
|---|---|
|
Active Comparator: Conventional Group
The treatment of 21 individuals in the conventional group will be done by the researcher.
Among the conservative treatment methods, hot pack(15 minutes) around the glenohumeral joint, conventional TENS(15 minutes) for painful points, ultrasound(1.5
watt / cm² power, 5 minutes) and exercise(passive and active range of motion) approaches will be applied.
Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week.
|
Hotpack, TENS, ultrasound and exercise
|
|
Active Comparator: Myofascial Release Group
Treatment of 21 individuals in the Myofascial Release group will be done by the researcher.
Among the conservative treatment methods, hot pack(15 minutes) around the glenohumeral joint, conventional TENS(15 minutes) for painful points, ultrasound(1.5
watt / cm² power, 5 minutes),exercise(passive and active range of motion) and myofascial release to subscapularis and serratus anterior muscles approaches will be applied.
Individuals will be asked to come to the center where the research will be conducted for a total of fifteen sessions for three weeks, five times a week.
Myofascial release will be done in the first five sessions of treatment programs.
|
Hotpack, TENS, ultrasound, exercise and myofascial release therapy for subscapularis and serratus anterior muscles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Change between baseline and first and 3 weeks
|
Pain sensations are scored between 0 and 10. 0 is the lowest pain, 10 the highest pain.
|
Change between baseline and first and 3 weeks
|
|
Range of motion (ROM) with Goniometer
Time Frame: Change between baseline and first and 3 weeks
|
Shoulder joint range of motion, The range of motion is measured between 0-180 degrees of flexion, 0-60 degrees of extension, 0-180 degrees of abduction, 0-50 degrees of abduction, internal rotation 0-90 degrees, external rotation 0-90 degrees.
|
Change between baseline and first and 3 weeks
|
|
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Time Frame: Change between baseline and first and 3 weeks
|
Upper extremity functionality levels, a value from 0 to 100 is obtained.
The higher the score, the higher the degree of disability.
|
Change between baseline and first and 3 weeks
|
|
Shoulder Pain and Disability Index (SPADI)
Time Frame: Change between baseline and first and 3 weeks
|
Specific shoulder pain and functions, all scores add up.
The higher the score, the higher the degree of disability.
|
Change between baseline and first and 3 weeks
|
|
Pittsburgh Sleep Quality Index (PUKİ)
Time Frame: Change between baseline and first and 3 weeks
|
Sleep quality, the scoring of the scale, which is evaluated by scoring each item between zero and three, is between 0-20.
A total score higher than five indicates poor sleep quality.
|
Change between baseline and first and 3 weeks
|
|
Short Form-36 (SF-36)
Time Frame: Change between baseline and first and 3 weeks
|
Quality of life, scoring of the scale is between 0-100.
100 is the highest score, 0 is the lowest.
|
Change between baseline and first and 3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1508796
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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