Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of Fibromyalgia

Tecnología e Innovación Médico Estética S.L.

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Whole body cryotherapy sessions

Study type: Interventional

Funder types: Industry

Identifiers

NCT03425903

TIME-CRY-2015-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Whole Body Cryotherapy sessions

Active Comparator group

Description:

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

Treatment:

Device: Whole body cryotherapy sessions

Control group

No Intervention group

Description:

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.