Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-14 @ 2:24 PM
Study NCT ID:
NCT01266733
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2010-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Sponsor:
Hospital Galdakao-Usansolo
Organization:
Study Overview
Official Title:
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: