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Completed

NCT Number: NCT00635895

Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients

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).

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Key information

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Lymph Drainage Therapy and Connective Tissue Massage

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

Other names: No drug was used

Primary outcomes

  1. Pain intensity VAS

    Time frame: 1 minute

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 10 minutes

  2. algometry

    Time frame: 1 munute

  3. Nottingham Health Profile

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Collaborators

  • Abant Izzet Baysal University
  • Hacettepe University

Registry information

Official study title

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

Acronym: FM

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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