Fibromyalgia
Conditions
Keywords
Fibromyalgia, Whole body cryotherapy
Brief summary
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.
Detailed description
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).
Interventions
DEVICEWhole body cryotherapy sessions
Whole body cryotherapy (WBC) 10 sessions of 3 minutes at a temperature of -196ºC (point of evaporation of liquid nitrogen), on the basis of three sessions a week.Fills in questionnaires.
Sponsors
Tecnología e Innovación Médico Estética S.L.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants received WBC sessions and after that become controls
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patiens with cardiovascular or psychiatric comorbidity * Cold intolerance * Changes in pharmacological treatment during the study * Body temperature over 37,5ºC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Index of Severity of Fibromyalgia (ICAF) | 8 weeks | Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping |
| General health questionnaire (SF36) | 8 weeks | It´s composed of 36 questions (items) that assess both positive and negative health states |
| Pain intensity measure. Visual Analogyc scale (VAS) | 8 weeks | Each patien marks in the scale the pain intensity scored 0-10 (0= no pain; 10= pain as can be) |
Countries
Spain
Outcome results
None listed