Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
1 other identifier
interventional
153
1 country
1
Brief Summary
The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 23, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedJune 18, 2015
December 1, 2010
2.8 years
December 23, 2010
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire)
Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention.
6 months
Secondary Outcomes (1)
Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale)
6 months
Study Arms (2)
Interdisciplinary treatment
EXPERIMENTALUsual treatment
NO INTERVENTIONInterventions
The Experimental Group received 6 weeks of interdisciplinary treatment of fibromyalgia combining coordinated psychological, medical, educational, and physiotherapeutic interventions delivered by a team that included a physician, a psychologist, and a physiotherapist.Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions. One session included 1 hour with the psychologist and 45 minutes of educational activities with the physician and psychologist, while the other session included 1 hour with the psychologist and 45 minutes with the physiotherapist.
The Control Group received the usual standard of care, which included pharmacologic treatment with a tricyclic antidepressant (amitriptyline, maximum dose of 75 mg/24h), an analgesic (paracetamol, maximum dose of 4 grams/24h), and a non-opioid central analgesic (tramadol, maximum dose of 400 mg/24h). The Experimental Group (EG) received 6 weeks of interdisciplinary treatment combining coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) delivered by a team that included a physician, a psychologist, and a physiotherapist. Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions.
Eligibility Criteria
You may qualify if:
- a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology
- being 18 years or older and
- having had continuous chronic pain for at least 6 months.
You may not qualify if:
- Patients were excluded if they did not agree to participate in the study,
- were suffering from a severe psychiatric or organic disorder, or
- were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, 48960, Spain
Related Publications (1)
Martin J, Torre F, Padierna A, Aguirre U, Gonzalez N, Matellanes B, Quintana JM. Impact of interdisciplinary treatment on physical and psychosocial parameters in patients with fibromyalgia: results of a randomised trial. Int J Clin Pract. 2014 May;68(5):618-27. doi: 10.1111/ijcp.12365. Epub 2014 Feb 20.
PMID: 24868587DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Torre, Doctor
Hospital Galdakao-Usansolo (Bizkaia) Spain
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 23, 2010
First Posted
December 24, 2010
Study Start
February 1, 2007
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
June 18, 2015
Record last verified: 2010-12