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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2017-06-09

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants received WBC sessions and after that become controls

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Whole body cryotherapy sessions

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whole 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No