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

This study has been completed.
Sponsor:
Collaborators:
Hacettepe University
Abant Izzet Baysal University
Information provided by:
Pamukkale University
ClinicalTrials.gov Identifier:
NCT00635895
First received: March 6, 2008
Last updated: March 7, 2008
Last verified: March 2008
  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

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

Resource links provided by NLM:


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
Active Comparator: 1
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
Other Name: No drug was used
Active Comparator: 2
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
Other Name: No drug was used

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Gamze Ekici, Pamukkale University
ClinicalTrials.gov Identifier: NCT00635895     History of Changes
Other Study ID Numbers: Ekici - 3, ISRCTN12345678
Study First Received: March 6, 2008
Last Updated: March 7, 2008
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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014