Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.

NCT03466008 | Completed

• 1 other identifier: B039201629783
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our aim was to determine whether Whole Body Cryotherapy (WBC) can result in improved pain status, perceived health, and quality of life in patients with fibromyalgia. It is hypothesized that this positive effect can be achieved through increased functional mobility and decreased pain intensity resulting from cold-induced modulation of the inflammation-immune axis.

Conditions

Fibromyalgia

Keywords

whole body cryotherapy; fibromyalgia; chronic pain; quality of life; perceived health

Outcome Measures

Primary Outcomes (1)

• pain status at 1 month from baseline

  pain score on a numerical scale (Subjective Numerical scale) likert rating 0 to 10 by the fibromyalgia patient 0 indicate no pain, 10 maximal pain value

  change from baseline at one month follow-ups

Secondary Outcomes (6)

• pain status at 2 weeks from baseline

  change from baseline at two weeks follow-ups

• functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire

  chnage from baseline at two weeks follow-ups

• functional status : the Oswestry Disability Index (ODI)

  change from baseline at one month follow-ups

• functional status : the Disability of the Arm, Shoulder and Hand (DASH) score

  change from baseline at one month follow-ups

• functional status : Lower Extremity Functional Scale (LEFS)

  change from baseline at one month follow-ups

Study Arms (2)

Whole body cryotherapy arm

EXPERIMENTAL

intervention consisted of 10 sessions of WBC (three minutes for each session) which were performed in addition to usual care in a standard cryotherapy room over a duration of 8 days.

Behavioral: Whole-Body Cryotherapy

Usual treatment arm

NO INTERVENTION

usual care

Interventions

Whole-Body Cryotherapy BEHAVIORAL

10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days.

Also known as: Usual intervention

Whole body cryotherapy arm

Eligibility Criteria

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

You may qualify if:

• Fibromyalgia diagnosis

You may not qualify if:

• cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases

Sponsors & Collaborators

• Haute École Robert Schuman Libramont: lead

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• guillaume polidori, Pr

  University of Reims

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, PT, PhD Student, Principal investigator

Model Details: between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 15, 2018
• Study Start: January 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: May 30, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share