Clinical trial NCT00635895: Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients
Official title: Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Manual Lymphatic Drainage
Connective Tissue Massage
Pain
Health Related Quality of Life
Randomized Controlled Trial
Lead sponsor: Pamukkale University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Abant Izzet Baysal University
First posted: 2008-03-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity VAS
timeFrame: 1 minute
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 10 minutes
measure: algometry
timeFrame: 1 munute
measure: Nottingham Health Profile
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Pamukkale University
name: Gamze Ekici, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant Izzet Baysal University
name: Yesim Bakar, Asist. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Turkan Akbayrak, Assoc.Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Inci Yuksel, Prof
role: STUDY_DIRECTOR
References: