Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients

Fibromyalgia Clinical Trial

— FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635895
• Other study ID #: Ekici - 3
• Secondary ID: ISRCTN12345678
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: March 7, 2008
• Start date: June 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2008
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Pamukkale University	Abant Izzet Baysal University, Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity VAS		1 minute	Yes
Secondary	Fibromyalgia Impact Questionnaire (FIQ)		10 minutes	Yes
Secondary	algometry		1 munute	Yes
Secondary	Nottingham Health Profile		10 minutes	Yes