Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients
FM
Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial
2 other identifiers
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 6, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedMarch 14, 2008
March 1, 2008
1.3 years
March 6, 2008
March 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity VAS
1 minute
Secondary Outcomes (3)
Fibromyalgia Impact Questionnaire (FIQ)
10 minutes
algometry
1 munute
Nottingham Health Profile
10 minutes
Study Arms (2)
1
ACTIVE COMPARATORManual Lymph Drainage Therapy is a manual therapy method
2
ACTIVE COMPARATORConnective Tissue Massage
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pamukkale Universitylead
- Hacettepe Universitycollaborator
- Abant Izzet Baysal Universitycollaborator
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 6, 2008
First Posted
March 14, 2008
Study Start
June 1, 2006
Primary Completion
September 1, 2007
Study Completion
October 1, 2007
Last Updated
March 14, 2008
Record last verified: 2008-03