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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425903
• Other study ID #: TIME-CRY-2015-01
• Status: Completed
• Phase: N/A
• First received: January 25, 2018
• Last updated: February 1, 2018
• Start date: November 16, 2016
• Est. completion date: June 9, 2017

Study information

• Verified date: February 2018
• Source: Tecnología e Innovación Médico Estética S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 9, 2017
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Tecnología e Innovación Médico Estética	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Tecnología e Innovación Médico Estética S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)	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.	8 weeks
Secondary	Combined Index of Severity of Fibromyalgia (ICAF)	Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping	8 weeks
Secondary	General health questionnaire (SF36)	It´s composed of 36 questions (items) that assess both positive and negative health states	8 weeks
Secondary	Pain intensity measure. Visual Analogyc scale (VAS)	Each patien marks in the scale the pain intensity scored 0-10 (0= no pain; 10= pain as can be)	8 weeks