Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Manual Lymph Drainage Therapy and Connective Tissue Massage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Manual Lymph Drainage Therapy is a manual therapy method | Other: Manual Lymph Drainage Therapy and Connective Tissue Massage<br>* 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<br>* Other names: No drug was used;|
| Active Comparator: 2<br>Connective Tissue Massage | Other: Manual Lymph Drainage Therapy and Connective Tissue Massage<br>* 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<br>* Other names: No drug was used;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity VAS |  | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire (FIQ) |  | 10 minutes | 
| algometry |  | 1 munute | 
| Nottingham Health Profile |  | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Manual Lymphatic Drainage, Connective Tissue Massage, Pain, Health Related Quality of Life, Randomized Controlled Trial