Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients

NCT ID: NCT00635895

Last Updated: 2008-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-10-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Manual Lymph Drainage Therapy is a manual therapy method

Group Type: ACTIVE_COMPARATOR

Manual Lymph Drainage Therapy and Connective Tissue Massage

Intervention Type: OTHER

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

Connective Tissue Massage

Group Type: ACTIVE_COMPARATOR

Manual Lymph Drainage Therapy and Connective Tissue Massage

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

No drug was used

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Abant Izzet Baysal University

OTHER

Sponsor Role: collaborator

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Pamukkale University

Principal Investigators

Gamze Ekici, PhD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Yesim Bakar, Asist. Prof.

Role: STUDY_DIRECTOR

Abant Izzet Baysal University

Turkan Akbayrak, Assoc.Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Inci Yuksel, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ISRCTN12345678

Identifier Type: -

Identifier Source: secondary_id

Ekici - 3

Identifier Type: -

Identifier Source: org_study_id