Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients (FM)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Lymph Drainage Therapy and Connective Tissue Massage
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Manual Lymphatic Drainage, Connective Tissue Massage, Pain, Health Related Quality of Life, Randomized Controlled Trial
Eligibility Criteria
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.
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Manual Lymph Drainage Therapy is a manual therapy method
Connective Tissue Massage
Outcomes
Primary Outcome Measures
Pain intensity VAS
Secondary Outcome Measures
Fibromyalgia Impact Questionnaire (FIQ)
algometry
Nottingham Health Profile
Full Information
NCT ID
NCT00635895
First Posted
March 6, 2008
Last Updated
March 7, 2008
Sponsor
Pamukkale University
Collaborators
Hacettepe University, Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT00635895
Brief Title
Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients
Acronym
FM
Official Title
Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pamukkale University
Collaborators
Hacettepe University, Abant Izzet Baysal University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study was designed to analyze and compare the effects of Manual Lymph Drainage Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Manual Lymphatic Drainage, Connective Tissue Massage, Pain, Health Related Quality of Life, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Manual Lymph Drainage Therapy is a manual therapy method
Arm Title
2
Arm Type
Active Comparator
Arm Description
Connective Tissue Massage
Intervention Type
Other
Intervention Name(s)
Manual Lymph Drainage Therapy and Connective Tissue Massage
Other Intervention Name(s)
No drug was used
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity VAS
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
10 minutes
Title
algometry
Time Frame
1 munute
Title
Nottingham Health Profile
Time Frame
10 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Ekici, PhD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yesim Bakar, Asist. Prof.
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Turkan Akbayrak, Assoc.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Inci Yuksel, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
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Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients
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