A Randomised Sham-controlled Study on the Effectiveness of Mild Water-filtered Infrared-A Whole-body Hyperthermia in Improving Symptoms and Quality of Life in Patients With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
研究概览
简要总结
This study will examine the effectiveness of water-filtered whole-body hyperthermia during an outpatient setting in patients with fibromyalgia.
The duration of the study is about 3 weeks with two treatment units per week and a passive period (follow-up measurement) of 24 weeks after the outpatient setting.
详细描述
A total of about 40 participants over 18 years of age are sought, who will be divided into two groups of equal size after inclusion in the study. All participants will receive the same amount of water-filtered whole-body hyperthermia within the outpatient setting. One group receives the gentle form of GKHT, the other group receives the classic, mild GHKT. All abnormalities are documented by the responsible therapists, doctors and nurses. Changes in the area of pain and functional limitations as well as the intake of required medication are also recorded.
Before the start and after the completion of the studies, within the clinical stay, blood parameters were collected. In order to determine the secondary effectiveness of different questionnaire values are also collected. These are also documented after week 12 and after week 24, by means of telephone enquiries.
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
- Single (Participant)
盲法说明
Single
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of fibromyalgia (FSQ)
- •Pain VAS >= 4,0
- •Signed declaration of consent
排除标准
- •Participation in other clinical studies
- •Contraindications for hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
- •Acute and / or feverish microbial infections
- •Patients with severe somatic, rheumatic concomitant endocrine or neurological diseases, in particular neurological diseases associated with cognitive disorders, severe liver or kidney and cardiac diseases
- •Patients who are permanently treated with opioids, cannabis, immunosuppressive drugs (e.g. corticoids, immunosuppressants) or alpha/beta-A(nta)gonists due to a disease from the group described above
- •Patients with pain due to a serious psychiatric illness (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) and serious systemic or neurological disorders
结局指标
主要结局
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
时间窗: Week 4
An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments.
次要结局
- Multidimensionl Fatigue Inventory (MFI-20)(Week 30)
- Fibromyalgia Impact Questionnaire (FIQ)(Week 30)
- Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)(Week 30)
- SF-36 health survey(Week 30)
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)(Week 30)
- Pittsburgh Sleep quality index (PSQI)(Week 30)
- Additional Treatments/Change of Medication(Week 30)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 30)
- Patient Global Impression of Change(Week 30)
- Pain Diary(Week 1-3)
- weight(Week 0)
- Patient Interview(Week 12)
- sex(Week 0)
- height(Week 0)
- marital status(Week 0)
- education(Week 0)
- job(Week 0)
- Adverse events (AE)(Week 1-3)
- age(Week 0)
- Shortform of PHQ-D (Patient Health Questionnaire)(Week 30)
研究者
Jost Langhorst
Prof.
Universität Duisburg-Essen