Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients - Full Text View

Sponsors and Collaborators:	Pamukkale University Hacettepe University Abant Izzet Baysal University
Information provided by:	Pamukkale University
ClinicalTrials.gov Identifier:	NCT00635895

Purpose

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).

Condition	Intervention
Fibromyalgia	Other: Manual Lymph Drainage Therapy and Connective Tissue Massage

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial

Further study details as provided by Pamukkale University:

Primary Outcome Measures:

Pain intensity VAS [ Time Frame: 1 minute ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
algometry [ Time Frame: 1 munute ] [ Designated as safety issue: Yes ]
Nottingham Health Profile [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	June 2006
Study Completion Date:	October 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Manual Lymph Drainage Therapy is a manual therapy method	Other: Manual Lymph Drainage Therapy and 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
2: Active Comparator Connective Tissue Massage	Other: Manual Lymph Drainage Therapy and 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

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

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635895

Locations

Turkey
Hacettepe University
Ankara, Turkey, 06100

Sponsors and Collaborators

Pamukkale University

Hacettepe University

Abant Izzet Baysal University

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

More Information

No publications provided

Responsible Party:	Pamukkale University ( Gamze Ekici )
Study ID Numbers:	Ekici - 3, ISRCTN12345678
Study First Received:	March 6, 2008
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00635895 History of Changes
Health Authority:	Turkey: Ethics Committee

Keywords provided by Pamukkale University:

Fibromyalgia
Manual Lymphatic Drainage
Connective Tissue Massage

Pain
Health Related Quality of Life
Randomized Controlled Trial

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Quality of Life
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Nervous System Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009