Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Patients With Fibromyalgia Syndrome (FS): A Randomized Double Blind Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change of 20% Total FIQ
研究概览
简要总结
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in 100 patients with primary Fibromyalgia Syndrome (FS).
详细描述
The fibromyalgia syndrome (FS) is a chronic condition that is characterized by chronic widespread pain, fatigue, sleep disorders, cognitive disturbances, physical and psychological distress. It was estimated that between 2.9 and 3.8% of the general population in Europe and the US are affected , with the majority of patients in clinical settings being female . Clinical research suggests that pharmacologic treatment alone is not the best approach for FS, and that an integrated approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.
Balneotherapy is one of the most commonly used non-pharmacological approaches for SF, but it is still being discussed and its role in modern medicine is still not clear. The action mechanisms of thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment.
The present randomized, controlled double blind trial aims to evaluate the efficacy and tolerability of balneotherapy with mineral water named "Debole of Vetriolo" in patients with primary SF fulfilling the 2010 ACR criteria.
Following confirmation that the patients fulfill the screening criteria and having obtained written informed consent, 100 patients will be randomized 1:1 and allocated to one of two groups using a computer-generated table of random numbers:
Group I (50 patients) will be treated with daily thermal-mineral bath with mineral water named "Debole of Vetriolo" for a total of 12 applications carried out over a period of two weeks at Levico Terme Spa Center (Levico Terme, Italy)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from FS according to American College of Rheumatology (ACR) criteria for at least 3 months and with a stable treatment for at least 4 weeks
- •Have a score of WPI≥7 and SS ≥ 5 or WPI 3-6 and SS≥9 screening and baseline visit
- •Provide written informed consent to participate in the study
排除标准
- •Concurrent participation in other therapeutic trials
- •Patients that have been treated with mud-pack therapy and/or balneotherapy in the last 6 months
- •Patients affected by neoplastic diseases in the last five years, with cardiovascular disease of recent onset, suffering from serious impairment of hematopoietic, renal and hepatic systems
- •Presence of concurrent autoimmune or inflammatory disease, such as, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, etc.
- •Pregnant and nursing mothers
- •Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, within two years)
- •Routine daily use of narcotic analgesics or history of substance abuse
- •Patients unable to complete the questionnaires
结局指标
主要结局
Change of 20% Total FIQ
时间窗: change from baseline at 15 days
FIQ
Change of 20% of VAS score
时间窗: change from baseline at 15 days
VAS score,
次要结局
- Quality of life assessed by SF-12(Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.)
- Anxiety evaluation by STAI(Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.)
- Widespread Pain assessed by WPI(Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.)
- Symptom Severity assessed by SS scale(Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.)
- Depression assessed by CES-D(Baseline time , after 2 weeks ,after 3 months, 6 months, following the beginning of the study.)
研究者
Fioravanti Antonella
Assistant of Professor
Azienda Ospedaliera Universitaria Senese