- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469996
Effects of Connective Tissue Massage in Patients With Fibromyalgia
June 21, 2024 updated by: Songül Bağlan Yentür, Firat University
Effects of Connective Tissue Massage and Self Myofascial Release in Patients With Fibromyalgia
Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation.
The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS.
At least 30 FMS patients will be included in the study.
Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated.
CTM will be practiced to study group and foam roller will be practiced to control group.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria.
It is often associated with symptoms such as decreased physical strength, fatigue, sleep disturbances, gastrointestinal disorders and psychiatric disorders such as depression.
Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation.
In the last two decades, massage applications using tools of various densities, materials, shapes and sizes (such as Foam Roller (FR), roller massagers, sticks or balls) and actively self-administered by individuals have rapidly gained popularity.
The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS.
At least 30 FMS patients will be included in the study.
Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated.
CTM will be practiced to study group and foam roller will be practiced to control group.
Treatments will be applied for 6 weeks, 2 days a week for a total of 12 sessions.
Study Type
Interventional
Enrollment (Estimated)
30
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
-
-
-
Elazığ, Turkey, 23100
- Recruiting
- Songul
-
Contact:
- Songul Baglan Yentur
- Phone Number: 04242370000
- Email: songulbaglan23@hotmail.com
-
Contact:
- Songul Baglan Yentur
- Email: songulbaglan23@hotmail.com
-
-
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:
- Being a woman
- Being diagnosed with FMS,
- Being between the ages of 18-65 and volunteering.
Exclusion Criteria:
- Neurological, infectious, endocrine and other inflammatory rheumatic diseases, severe psychological disorders, any condition that prevents exercise (advanced cardiac respiratory or orthopedic problems),
- Malignancy
- Being pregnant
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: Connective tissue massage group
Connective tissue massage will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks.
While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively.
|
Connective Tissue Massage will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks.
While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively.
|
|
Experimental: Self myofascial relaxation group
Self myofascial relaxation will be applied using foam roller.
The practice will continue two days a week for 6 weeks.
Foam roller exercise is performed in the supine position with knees bent, hands locked behind the neck and foam roller is placed between the shoulder blades.
|
Self myofascial relaxation will be practiced with foam roller in patients with Fibromyalgia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
disability
Time Frame: 2 minutes
|
Fibromyalgia Impact Questionnaire is a scale consisting of 10 questions to assess the health status and physical functionality of an individual diagnosed with FM.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain assesment
Time Frame: 1 minute
|
Pain will be evaluated with Visual Analog Scale.
Patients will be asked to rate the severity of pain between 0-10.
|
1 minute
|
|
Quality of life assesment
Time Frame: 2 minutes
|
Quality of life will be assessed with the Health Assessment Questionnaire (HRA).
The HRA is one of the first disability questionnaires used in adults with arthritis.
The highest scores of each subgroup are summed and the result is divided by eight to obtain the participant's SDQ score.
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
June 20, 2024
Primary Completion (Estimated)
August 20, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
June 14, 2024
First Submitted That Met QC Criteria
June 21, 2024
First Posted (Actual)
June 24, 2024
Study Record Updates
Last Update Posted (Actual)
June 24, 2024
Last Update Submitted That Met QC Criteria
June 21, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/08-06
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.
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