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临床试验/NCT01266733
NCT01266733已完成2 期

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

Hospital Galdakao-Usansolo2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire)

时间窗: 6 months

Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention.

次要结局

  • Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale)(6 months)

研究者

发起方
Hospital Galdakao-Usansolo
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Josune Martin Corral

PhD

Hospital Galdakao-Usansolo

研究点 (2)

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