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

NCT ID: NCT03466008

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-05-30

Brief Summary

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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.

Detailed Description

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24 patients with fibromyalgia were randomized into 2 groups (n=11 in the WBC group, n=13 in the control group). In the WBC group, 10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days. Patients in the control group did not change anything in their everyday activities. Several self-reported variables relating to perceived health were measured repeatedly (pain intensity, functional mobility, and quality of life).

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Whole body cryotherapy arm

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.

Group Type EXPERIMENTAL

Whole-Body Cryotherapy

Intervention Type BEHAVIORAL

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

Usual treatment arm

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whole-Body Cryotherapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Usual intervention

Eligibility Criteria

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Inclusion Criteria

Fibromyalgia diagnosis

Exclusion Criteria

cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haute École Robert Schuman Libramont

OTHER

Sponsor Role lead

Responsible Party

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François Tubez

Physical Therapist, PT, PhD Student, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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guillaume polidori, Pr

Role: STUDY_DIRECTOR

University of Reims

Other Identifiers

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B039201629783

Identifier Type: -

Identifier Source: org_study_id

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