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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03425903
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Tecnología e Innovación Médico Estética S.L.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Whole body cryotherapy sessions Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants received WBC sessions and after that become controls
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. General health questionnaire (SF36) [ Time Frame: 8 weeks ]
    It´s composed of 36 questions (items) that assess both positive and negative health states

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Tecnología e Innovación Médico Estética
Madrid, Spain, 28050
Sponsors and Collaborators
Tecnología e Innovación Médico Estética S.L.
Investigators
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Principal Investigator: Javier Rivera, Doctor Hospital Gregorio Marañón-IPR
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tecnología e Innovación Médico Estética S.L.
ClinicalTrials.gov Identifier: NCT03425903    
Other Study ID Numbers: TIME-CRY-2015-01
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tecnología e Innovación Médico Estética S.L.:
Fibromyalgia, Whole body cryotherapy
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases