Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients (FM)

March 7, 2008 updated by: Pamukkale University

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

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Manual Lymph Drainage Therapy is a manual therapy method
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
Other Names:
  • No drug was used
Active Comparator: 2
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
Other Names:
  • No drug was used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity VAS
Time Frame: 1 minute
1 minute

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 7, 2008

Last Verified

March 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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