Balneotherapy in Primary Fibromyalgia: Impact on Algo-functional Indexes, Quality of Life, and Anxio-depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Minimal Clinically Important Difference (MCID)
研究概览
简要总结
Balneotherapy (BT) is recommended as non-pharmacological treatment for Fibromyalgia Syndrome (FS). BT efficacy is based on beneficial properties of both mud bath and stay in a spa environment. The main aim of this multicentric prospective longitudinal cohort study is to evaluate BT effectiveness in patients withFS. All FS patients with a stable treatment in the past month and a Fibromyalgia Impact Questionnaire (FIQ) score ≥39 will be enrolled after providing written informed consent. Patients will be divided into two groups based on whether or not BT is added to usual therapy: BT Group and Control Group. Each patients will be assessed at baseline, after 15 and 45 days in BT Group and at baseline and after 15 days in Control group with an assessment of pain by Visual Analogue Scale, FIQ, Short-Form Health Survey, State-Trait Anxiety Inventory (STAI) and Center for Epidemiologic Studies Depression Scale (CES-D). Collected data will provide a new insight of BT role and the removal of daily stress in FS management
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary FS according to the 2010 American College of Rheumatology (ACR) criteria;
- •Pharmacological and non pharmacological treatment stable for at least 3 months;
- •FIQ-Total score ≥ 39
排除标准
- •Secondary FS;
- •Primary FS patients actually enrolled in other clinical trials;
- •Patients who had receveid a cycle of BT or of mud-bath in the previous 6 months;
- •Patients treated with intra-articular steroid injections of any joints in the previous 3 months;
- •Pregnancy or breastfeeding;
- •Cognitive or psychiatric disorders and history of substance abuse;
- •Absolute and relative contraindications to BT
结局指标
主要结局
Minimal Clinically Important Difference (MCID)
时间窗: 15 days
Percentage of patients achieving MCDI, defined as a reduction\>14% of FIQ-total score
次要结局
- Fibromyalgia Impact Questionnaire (FIQ)(basal time;15 days;45 days)
- Adverse events(15 days)
- Visual Analogue Scale (VAS)(basal time;15 days;45 days)
- Short-Form Health Survey (SF-12)(basal time;15 days;45 days)
- State-Trait Anxiety Inventory (STAI)(basal time;15 days;45 days)
- Center for Epidemiologic Studies Depression Scale (CES-D)(basal time;15 days;45 days)
研究者
fioravanti antonella
Scientific Coordinator
Azienda Ospedaliera Universitaria Senese