Clinical trial NCT03425903: Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of Fibromyalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia, Whole body cryotherapy
Lead sponsor: Tecnología e Innovación Médico Estética S.L.
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received WBC sessions and after that become controls
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 8 weeks
Secondary outcomes:
measure: Combined Index of Severity of Fibromyalgia (ICAF)
timeFrame: 8 weeks
measure: General health questionnaire (SF36)
timeFrame: 8 weeks
measure: Pain intensity measure. Visual Analogyc scale (VAS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Tecnología e Innovación Médico Estética
Study officials:
affiliation: Hospital Gregorio Marañón-IPR
name: Javier Rivera, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rivera J, Tercero MJ, Salas JS, Gimeno JH, Alejo JS. The effect of cryotherapy on fibromyalgia: a randomised clinical trial carried out in a cryosauna cabin. Rheumatol Int. 2018 Dec;38(12):2243-2250. doi: 10.1007/s00296-018-4176-0. Epub 2018 Oct 23.