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Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment

NCT01266733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2015-06-18

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

Interdisciplinary treatment

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.

BEHAVIORAL

Interdisciplinary treatment of fibromyalgia

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.

Sponsors & Collaborators

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Fernando Torre, Doctor · Hospital Galdakao-Usansolo (Bizkaia) Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266733 on ClinicalTrials.gov