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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Interdisciplinary treatment
Interdisciplinary treatment of fibromyalgia
Sponsored by
Hospital Galdakao-Usansolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, non pharmacological intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Galdakao-Usansolo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interdisciplinary treatment

Usual treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale)
Patients with fibromyalgia completed the HADS at baseline and again 6 months after the intervention

Full Information

First Posted
December 23, 2010
Last Updated
June 17, 2015
Sponsor
Hospital Galdakao-Usansolo
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1. Study Identification

Unique Protocol Identification Number
NCT01266733
Brief Title
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Official Title
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Galdakao-Usansolo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, non pharmacological intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interdisciplinary treatment
Arm Type
Experimental
Arm Title
Usual treatment
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary treatment
Other Intervention Name(s)
Interdisciplinary treatment of fibromyalgia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary treatment of fibromyalgia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire)
Description
Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale)
Description
Patients with fibromyalgia completed the HADS at baseline and again 6 months after the intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Torre, Doctor
Organizational Affiliation
Hospital Galdakao-Usansolo (Bizkaia) Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
State/Province
Bizkaia
ZIP/Postal Code
48960
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24868587
Citation
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.
Results Reference
derived

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

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