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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466008
• Other study ID #: B039201629783
• Status: Completed
• Phase: N/A
• First received: February 2, 2018
• Last updated: March 8, 2018
• Start date: January 1, 2017
• Est. completion date: May 30, 2017

Study information

• Verified date: March 2018
• Source: Haute École Robert Schuman Libramont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Fibromyalgia diagnosis

Exclusion Criteria:

cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haute École Robert Schuman Libramont

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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