Adhesive CapsulitisNCT04756167
Effect of Myofascial Relaxation on Individuals With Adhesive Capsulitis
A study testing Conventional Treatment and Myofascial Release Treatment in people with Adhesive Capsulitis, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
In the study, the investigators aimed to investigate the effects of myofascial release method on pain, functionality and quality of life in individuals with adhesive capsulitis. 42 individuals willing to participate in the study will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Conventional Treatment and Myofascial Release Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with adhesive capsulitis
- Being 18 years or older
- Agree to voluntarily participate in research
Who cannot join
- 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
Show all 9Show fewer
- Individuals with bone tumors or other malignant diseases
- Having mental and cognitive problems
- Physiotherapy or manual therapy on the same shoulder 6 months ago
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Levent Hospital
Istanbul, Kağıthane, 34394
About this study
Official title: The Effect of Myofascial Relaxation on Pain, Functionality and Quality of Life in Individuals With Adhesive Capsulitis: A Randomized Controlled Single-Blind Study
In the study, the investigators aimed to investigate the effects of myofascial release method on pain, functionality and quality of life in individuals with adhesive capsulitis. 42 individuals willing to participate in the study will be included. Participants will be randomly divided into two groups, the conventional group and the myofascial release group. Evaluations will be made by another physiotherapist with a single eye blindness. Hotpack, TENS, ultrasound and exercise will be applied jointly to both groups in the study. In addition to the myofascial release group, myofascial release will be applied on the subscapularis and serratus anterior muscles. 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. Participants' pain before the first treatment, at the end of the 5th treatment and after the 15th treatment with Visual Analogue Scale (VAS), shoulder joint range of motion (ROM) with Goniometer, upper extremity functionality level Arm, Shoulder and Hand Problems Questionnaire (DASH) specific shoulder pain and functions will be evaluated with the Shoulder Pain and Disability Index (SPADI), sleep quality with Pittsburgh Sleep Quality Index (PSQI), and quality of life with Short Form-36 (SF-36). Statistical analysis to be used in the investigators study will be made with the Statistical Package for the Social Sciences 20.0 package program.
Read the 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.
- Conditions
- Adhesive Capsulitis
- Being tested
- Conventional Treatment, Myofascial Release Treatment
- Keywords
- muscle relaxation, quality of life, range of motion, shoulder pain, sleep
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TreatmentOther
Hotpack, TENS, ultrasound and exercise
Myofascial Release TreatmentOther
Hotpack, TENS, ultrasound, exercise and myofascial release therapy for subscapularis and serratus anterior muscles
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Active comparator | 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. Receives: Other: Conventional Treatment |
| Myofascial Release Group | Active comparator | 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. Receives: Other: Myofascial Release Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain sensations are scored between 0 and 10. 0 is the lowest pain, 10 the highest pain.
Measured: Change between baseline and first and 3 weeks
Range of motion (ROM) with Goniometer
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.
Measured: Change between baseline and first and 3 weeks
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Upper extremity functionality levels, a value from 0 to 100 is obtained. The higher the score, the higher the degree of disability.
Measured: Change between baseline and first and 3 weeks
Shoulder Pain and Disability Index (SPADI)
Specific shoulder pain and functions, all scores add up. The higher the score, the higher the degree of disability.
Measured: Change between baseline and first and 3 weeks
Pittsburgh Sleep Quality Index (PUKİ)
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.
Measured: Change between baseline and first and 3 weeks
Short Form-36 (SF-36)
Quality of life, scoring of the scale is between 0-100. 100 is the highest score, 0 is the lowest.
Measured: Change between baseline and first and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Feb 2021
- Primary completion28 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The individuals are randomly allocated into conventional and myofascial release groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra TAPAN, Bahçeşehir University
- Investigators
- Leyla Ataş Balcı, Assist Prof, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756167
- Sponsor's protocol ID
- 1508796
- Status last verified
- May 2021
- First submitted
- 1 Feb 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Relaxation on Pain, Functionality and Quality of Life in Individuals With Adhesive Capsulitis: A Randomized Controlled Single-Blind Study
- ClinicalTrials.gov ID
- NCT04756167
- Acronym / sponsor ID
- 1508796
- Conditions
- Adhesive Capsulitis
- Keywords
- muscle relaxation, quality of life, range of motion, shoulder pain, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the study, the investigators aimed to investigate the effects of myofascial release method on pain, functionality and quality of life in individuals with adhesive capsulitis. 42 individuals willing to participate in the study will be included. Participants will be randomly divided into two groups, the conventional group and the myofascial release group. Evaluations will be made by another physiotherapist with a single eye blindness. Hotpack, TENS, ultrasound and exercise will be applied jointly to both groups in the study. In addition to the myofascial release group, myofascial release will be applied on the subscapularis and serratus anterior muscles. 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. Participants' pain before the first treatment, at the end of the 5th treatment and after the 15th treatment with Visual Analogue Scale (VAS), shoulder joint range of motion (ROM) with Goniometer, upper extremity functionality level Arm, Shoulder and Hand Problems Questionnaire (DASH) specific shoulder pain and functions will be evaluated with the Shoulder Pain and Disability Index (SPADI), sleep quality with Pittsburgh Sleep Quality Index (PSQI), and quality of life with Short Form-36 (SF-36). Statistical analysis to be used in the investigators study will be made with the Statistical Package for the Social Sciences 20.0 package program.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The individuals are randomly allocated into conventional and myofascial release groups
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Active comparator | Other: Conventional TreatmentThe 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. |
| Myofascial Release Group | Active comparator | Other: Myofascial Release TreatmentTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with adhesive capsulitis
- Being 18 years or older
- Agree to voluntarily participate in research
Key exclusion criteria (9 listed)
- Cervical disc hernias
- Neuromuscular diseases
- Full thickness rotator cuff tears
- Shoulder impingement syndrome
- Individuals with corticosteroid injection into the shoulder joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional TreatmentHotpack, TENS, ultrasound and exercise | Other | Conventional Group |
| Myofascial Release TreatmentHotpack, TENS, ultrasound, exercise and myofascial release therapy for subscapularis and serratus anterior muscles | Other | Myofascial Release Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla Ataş Balcı, Assist Prof study director
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Treatment and Myofascial Release Treatment in people with Adhesive Capsulitis, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Change between baseline and first and 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.