- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05063188
Connective Tissue Massage With Fibromyalgia
Is Connective Tissue Massage Effective In Individuals With Fibromyalgia?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Denizli
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Pamukkale, Denizli, Turkey, 20070
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:(a) having FM diagnosis according to American College of Rheumatology 2016 criteria, (b) being a women, (c) aged 20-65. (d) being stable in drug use for at least 6 months or more. (e) being volunteer to participate in this study.
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Exclusion Criteria:(a) have been exercising regularly for the past three months, (b) the presence of uncontrolled cardiopulmonary disease, (c) the presence of orthopedic, neurological or mental problems that may prevent exercise, (d) having undergone any surgery in the last six months for both groups, (e) pregnancy, (f) presence of malignancy, (g) not being able to participate in at least 75% of the training.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
Exercises were applied 3 times for 6 weeks, a total of 18 sessions.
One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total).
Connective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively.
|
Active Comparator: Control group
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Exercises were applied 3 times for 6 weeks, a total of 18 sessions.
One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Location Inventory
Time Frame: 10 min
|
10 min
|
Fibromyalgia Impact Questionnaire
Time Frame: 15 min
|
15 min
|
Health Assessment Questionnaire
Time Frame: 10 min
|
10 min
|
Beck Anxiety Inventory
Time Frame: 10 min
|
10 min
|
Short Form-36
Time Frame: 10 min
|
10 min
|
Biopsychosocial Questionnaire
Time Frame: 15 min
|
15 min
|
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
- Connective Tissue Massage
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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