Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT03425903|
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: Whole body cryotherapy sessions||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||All participants received WBC sessions and after that become controls|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 16, 2016|
|Actual Primary Completion Date :||June 9, 2017|
|Actual Study Completion Date :||June 9, 2017|
Active Comparator: 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
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.
No Intervention: 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.
- Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 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.
- Combined Index of Severity of Fibromyalgia (ICAF) [ Time Frame: 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) [ Time Frame: 8 weeks ]It´s composed of 36 questions (items) that assess both positive and negative health states
- Pain intensity measure. Visual Analogyc scale (VAS) [ Time Frame: 8 weeks ]Each patien marks in the scale the pain intensity scored 0-10 (0= no pain; 10= pain as can be)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425903
|Tecnología e Innovación Médico Estética|
|Madrid, Spain, 28050|
|Principal Investigator:||Javier Rivera, Doctor||Hospital Gregorio Marañón-IPR|