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

NCT03425903 | Completed

• 1 other identifier: TIME-CRY-2015-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Whole body cryotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Combined Index of Severity of Fibromyalgia (ICAF)

  8 weeks

• General health questionnaire (SF36)

  8 weeks

• Pain intensity measure. Visual Analogyc scale (VAS)

  8 weeks

Study Arms (2)

Whole Body Cryotherapy sessions

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Whole body cryotherapy sessions 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.

Whole Body Cryotherapy sessions

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patiens with cardiovascular or psychiatric comorbidity
• Cold intolerance
• Changes in pharmacological treatment during the study
• Body temperature over 37,5ºC

Sponsors & Collaborators

• Tecnología e Innovación Médico Estética S.L.: lead

Study Sites (1)

Tecnología e Innovación Médico Estética

Madrid, 28050, Spain

Location

Related Publications (1)

• Rivera J, Tercero MJ, Salas JS, Gimeno JH, Alejo JS. The effect of cryotherapy on fibromyalgia: a randomised clinical trial carried out in a cryosauna cabin. Rheumatol Int. 2018 Dec;38(12):2243-2250. doi: 10.1007/s00296-018-4176-0. Epub 2018 Oct 23.

  PMID: 30353267 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Javier Rivera, Doctor

  Hospital Gregorio Marañón-IPR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants received WBC sessions and after that become controls

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 8, 2018
• Study Start: November 16, 2016
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)