Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- pain status at 1 month from baseline
研究概览
简要总结
Our aim was to determine whether Whole Body Cryotherapy (WBC) can result in improved pain status, perceived health, and quality of life in patients with fibromyalgia. It is hypothesized that this positive effect can be achieved through increased functional mobility and decreased pain intensity resulting from cold-induced modulation of the inflammation-immune axis.
详细描述
24 patients with fibromyalgia were randomized into 2 groups (n=11 in the WBC group, n=13 in the control group). In the WBC group, 10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days. Patients in the control group did not change anything in their everyday activities. Several self-reported variables relating to perceived health were measured repeatedly (pain intensity, functional mobility, and quality of life).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Fibromyalgia diagnosis
排除标准
- •cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
研究组 & 干预措施
Whole body cryotherapy arm
intervention consisted of 10 sessions of WBC (three minutes for each session) which were performed in addition to usual care in a standard cryotherapy room over a duration of 8 days.
干预措施: Whole-Body Cryotherapy (Behavioral)
Usual treatment arm
usual care
结局指标
主要结局
pain status at 1 month from baseline
时间窗: change from baseline at one month follow-ups
pain score on a numerical scale (Subjective Numerical scale) likert rating 0 to 10 by the fibromyalgia patient 0 indicate no pain, 10 maximal pain value
次要结局
- functional status : the Oswestry Disability Index (ODI)(change from baseline at one month follow-ups)
- functional status : the Disability of the Arm, Shoulder and Hand (DASH) score(change from baseline at one month follow-ups)
- functional status : Lower Extremity Functional Scale (LEFS)(change from baseline at one month follow-ups)
- health related quality of life (HRQoL)(change from baseline to one month follow-ups)
- pain status at 2 weeks from baseline(change from baseline at two weeks follow-ups)
- functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire(chnage from baseline at two weeks follow-ups)
研究者
François Tubez
Physical Therapist, PT, PhD Student, Principal investigator
Haute École Robert Schuman Libramont