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

This study has been completed.
Sponsor:
Information provided by:
Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier:
NCT01266733
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Behavioral: Interdisciplinary treatment
Behavioral: Interdisciplinary treatment of fibromyalgia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment

Resource links provided by NLM:


Further study details as provided by Hospital Galdakao-Usansolo:

Primary Outcome Measures:
  • Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention.


Secondary Outcome Measures:
  • Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients with fibromyalgia completed the HADS at baseline and again 6 months after the intervention


Enrollment: 153
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interdisciplinary treatment 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.
Other Name: Interdisciplinary treatment of fibromyalgia
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.
Other Name: Interdisciplinary treatment of fibromyalgia
No Intervention: Usual treatment 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.
Other Name: Interdisciplinary treatment of fibromyalgia

Detailed Description:

Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, with a prevalence in general adult populations estimated at between 0.7% and 3.3%. In Spain, the prevalence of FM is 2-3%; it affects mainly women, with new diagnoses peaking between the ages of 40 and 49 years. In certain populations, however, the prevalence may be much higher, as in 15% of patients referred from internal medicine units or 12% of patients referred to rheumatology specialists in Spain.

Fibromyalgia produces various degrees of disability and pain. It also has a clear impact on health-related quality of life (HRQoL). Burckhardt et al. observed lower HRQoL among patients with fibromyalgia than among healthy subjects. Indeed, the HRQoL for those with FM was similar to that of patients with insulin-dependent diabetes mellitus or chronic obstructive pulmonary disease. Among patients with non-cancer chronic pain referred to the pain management unit at our institution, those with bone and joint pain and with FM had the worst progress 6 months after diagnosis as measured by HRQoL.

The characteristics of FM, such as its complex and unknown etiology, wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. As a result, no consensus yet exists regarding the best therapeutic approaches, and treatment of FM presents a challenge for clinicians. Clinical research suggests that pharmacologic treatment alone is not the best approach for FM, and that an integrated biopsychosocial approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.

In our hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit. We established a clinical trial in this population to assess improvement in HRQoL following 6 months of interdisciplinary treatment compared to the usual treatment, as well as to identify predictors for improvement in HRQoL.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266733

Locations
Spain
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, Spain, 48960
Sponsors and Collaborators
Hospital Galdakao-Usansolo
Investigators
Principal Investigator: Fernando Torre, Doctor Hospital Galdakao-Usansolo (Bizkaia) Spain
  More Information

No publications provided by Hospital Galdakao-Usansolo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerente Hospital Galdakao-Usansolo: D. Santiago Rabanal, Fernando Torre
ClinicalTrials.gov Identifier: NCT01266733     History of Changes
Other Study ID Numbers: 2006111057
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: United States: Federal Government
Spain: Ministry of Health

Keywords provided by Hospital Galdakao-Usansolo:
fibromyalgia, non pharmacological intervention

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 30, 2014