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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Whole-Body Cryotherapy

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Fibromyalgia diagnosis

Exclusion Criteria:

cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Usual intervention
No Intervention: Usual treatment arm; usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain status at 2 weeks from baseline	pain score on a Subjective Numerical scale 0 to 10; likert rating 0 to 10 by the fibromyalgia patient 0 indicate no pain, 10 maximal pain value	change from baseline at two weeks follow-ups
functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire	Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain There are 10 questions (items). The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. If the first statement is marked, the section score = 0, If the last statement is marked, it = 5 If all ten sections are completed the score is calculated as followed: Example: 10 (total score of the patient), 50 (total possible raw score), 10/50 x 100 = 20% If one section is missed or not applicable, the score is calculated as followed: Example: 15 (total score of the patient), 45 (total possible score), 15/45 x 100 = 30%	chnage from baseline at two weeks follow-ups
functional status : the Oswestry Disability Index (ODI)	Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain There are 10 questions (items). The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. If the first statement is marked, the section score = 0, If the last statement is marked, it = 5 If all ten sections are completed the score is calculated as followed: Example: 10 (total score of the patient), 50 (total possible raw score), 10/50 x 100 = 20% If one section is missed or not applicable, the score is calculated as followed: Example: 15 (total score of the patient), 45 (total possible score), 15/45 x 100 = 30%	change from baseline at one month follow-ups
functional status : the Disability of the Arm, Shoulder and Hand (DASH) score	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. DASH Scoring Formula = ([(sum of n responses)/n] -1)(25) where n represents the number of completed items. The score on both test ranges from 0 (no disability) to 100 (most severe disability).Minimal Detectable Change (MDC) is between 12.75% - 17.23%	change from baseline at one month follow-ups
functional status : Lower Extremity Functional Scale (LEFS)	The test can be used to evaluate the impairment of a patient with lower extremity musculoskeletal condition or disorders. Can be used clinically to measure the patients' initial function, ongoing progress, and outcome as well as to set functional goals.In 1999, Binkley et al. developed the Lower Extremity Functional Scale (LEFS), a patient-reported lower limb function questionnaire applicable to a wide spectrum of outpatients with a lower limb musculoskeletal condition. The LEFS consists of 20 items, each scored on a 5-point scale (0 to 4). The total score varies from 0 to 80, with higher scores representing better a functional status.	change from baseline at one month follow-ups
health related quality of life (HRQoL)	physical functioning (PCS) and mental functioning (MCS) from the SF-36 questionnaire The score on both test ranges from 0 (poor health related quality of life) to 100 (better health related quality of life value)	change from baseline to one month follow-ups

Collaborators and Investigators

• Sponsor: Haute École Robert Schuman Libramont
• Investigators: Study Director: guillaume polidori, Pr, University of Reims

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: chronic pain; quality of life; fibromyalgia; whole body cryotherapy; perceived health
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: B039201629783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: confidential personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No