- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635895
Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients (FM)
Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The lack of specific disease mechanisms is reflected in the fact that no cure has been found for the disease. Thus, the many interventions which are advocated in FM are targeted against the more general characteristics of pain and disability. Current pharmacological interventions have limited efficacy. There is an increasing consensus that therapy should also include non-pharmacological approaches. Manual therapy techniques are composed of a variety of procedures directed at the musculoskeletal structures in the treatment of pain. Two major subcategories exist that divide these techniques into those which produce joint motion and those which do not. The first subcategory includes manipulation, mobilization, and manual traction. The second subcategory involves both generalized soft tissue therapies, such as the many types of massage, and focal soft tissue therapy (10).
Consequently, there is currently no recognized effective treatment for FM patients. In addition, there is limited number of study dealing with the effect of manual therapy techniques on FM. Although, there were some studies about Manual Lymph Drainage Therapy (MLDT) and Connective Tissue Massage (CTM) in FM. There wasn't found any study concerning the comparison of the effects of MLDT and CTM. In this study, MLDT and CTM were used for FM, which are included in the second subcategory of manual therapy techniques.
Based on positive results of some studies about MLDT and CTM in FM, this study was planned to test and compare the effects of MLDT and CTM in terms of pain, health status and HRQoL in females with FM using a randomized control trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06100
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female outpatients
- being ≥ 25 years or older
- being met the criteria for FM as defined by the American College of Rheumatology
- having pain with the onset at least 3 months before baseline visit
- pain in the neck or shoulder region
- have never been treated for FM
- being volunteer for participating
Exclusion Criteria:
- pain from traumatic injury or structural or regional rheumatic disease,
- chronic infection,
- fever or an increased tendency to bleed,
- severe physical impairment,
- signs of tendinitis,
- cardiopulmonary disorder,
- inflammatory arthritis,
- autoimmune disease,
- uncontrolled endocrine disorder,
- allergic disorder,
- pregnancy or breast-feeding,
- malignancy,
- unstable medical or psychiatric illness or medication usage.
- They were asked not to use antidepressant, myorelaxant, and non-steroid anti-inflammatory drugs during three days before the first appointment and the treatment sessions and the evaluation process after the treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Manual Lymph Drainage Therapy is a manual therapy method
|
The treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups
Other Names:
|
Active Comparator: 2
Connective Tissue Massage
|
The treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity VAS
Time Frame: 1 minute
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 10 minutes
|
10 minutes
|
algometry
Time Frame: 1 munute
|
1 munute
|
Nottingham Health Profile
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gamze Ekici, PhD, Pamukkale University
- Study Director: Yesim Bakar, Asist. Prof., Abant Izzet Baysal University
- Study Director: Turkan Akbayrak, Assoc.Prof., Hacettepe University
- Study Director: Inci Yuksel, Prof, Hacettepe University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ekici - 3
- ISRCTN12345678
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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