Clinical Research, Randomized, Open, Unmasked, Controlled, Cross-group, Active-treatment, to Evaluate the Clinical Efficacy of Whole Body Cryotherapy (WBC) in the Cryosense TCT Cabin for the Treatment of Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8 weeks.
详细描述
The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin, on the main clinical manifestations of patients with Fibromyalgia (FM).
A randomized, open and crossed 8-week clinical trial comparing a WBC intervention with the waiting list control group. Patients diagnosed with FM according to ACR 2010 criteria, in treatment and regular follow-up recruited consecutively. Two groups were made, one of intervention and one of waiting list which served as control during the first phase. At the end of the first phase, and after a week of washout, the groups crossed and went on to carry out the second phase following the opposite intervention. The pharmacological treatment was not modified during the entire study.
Trial endpoints were changed in pain after 2 and 4 weeks, measured by a visual analogue scale (VAS) and burden of disease, evaluated by the Fibromyalgia Impact Questionnaire(FIQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 80 years old
- •Diagnosis of Fibromyalgia according to ACR criteria
- •More than 1 year from diagnosis
- •Lack of response or partial response to previous treatment
- •In case of women,commitment not to get pregnant during the study.
排除标准
- •Patiens with cardiovascular or psychiatric comorbidity
- •Cold intolerance
- •Changes in pharmacological treatment during the study
- •Body temperature over 37,5ºC
研究组 & 干预措施
Whole Body Cryotherapy sessions
10 Whole Body Cryotherapy sessions administered on alternate days. Patient fills the questionaires and then comes into the cabin wearing only underwear. The door is closed and the session begins, with the release of nitrogen gas to the cabin indoors, which will be in contact with the patient's body surface for 3 minutes. The intervention is performed on alternate days, so 3 sessions per week are administered. Afterwards will be compared when intervening as an control group without sessions, and with 3 visits per week and fills in the questionnaires
干预措施: Whole body cryotherapy sessions (Device)
Control group
Without sessions. Patient attends a control visit weekly, for 3 consecutive weeks and fills in the questionnaires to control the variables while treatment is not applied. Afterwards will be compared when intervening as an intervention group receiving 3 sessions per week and fills in the questionnaires.
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 8 weeks
This instrument composed of 10 items, measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
次要结局
- Combined Index of Severity of Fibromyalgia (ICAF)(8 weeks)
- General health questionnaire (SF36)(8 weeks)
- Pain intensity measure. Visual Analogyc scale (VAS)(8 weeks)