Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole-Body Cryotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia focused on measuring whole body cryotherapy, fibromyalgia, chronic pain, quality of life, perceived health
Eligibility Criteria
Inclusion Criteria:
Fibromyalgia diagnosis
Exclusion Criteria:
cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Whole body cryotherapy arm
Usual treatment arm
Arm Description
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.
usual care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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%
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%
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%
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.
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)
Full Information
NCT ID
NCT03466008
First Posted
February 2, 2018
Last Updated
March 8, 2018
Sponsor
Haute École Robert Schuman Libramont
1. Study Identification
Unique Protocol Identification Number
NCT03466008
Brief Title
Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Official Title
Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haute École Robert Schuman Libramont
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
whole body cryotherapy, fibromyalgia, chronic pain, quality of life, perceived health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole body cryotherapy arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual treatment arm
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Whole-Body Cryotherapy
Other Intervention Name(s)
Usual intervention
Intervention Description
10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days.
Primary Outcome Measure Information:
Title
pain status at 1 month from baseline
Description
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
Time Frame
change from baseline at one month follow-ups
Secondary Outcome Measure Information:
Title
pain status at 2 weeks from baseline
Description
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
Time Frame
change from baseline at two weeks follow-ups
Title
functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire
Description
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%
Time Frame
chnage from baseline at two weeks follow-ups
Title
functional status : the Oswestry Disability Index (ODI)
Description
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%
Time Frame
change from baseline at one month follow-ups
Title
functional status : the Disability of the Arm, Shoulder and Hand (DASH) score
Description
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%
Time Frame
change from baseline at one month follow-ups
Title
functional status : Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
change from baseline at one month follow-ups
Title
health related quality of life (HRQoL)
Description
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)
Time Frame
change from baseline to one month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fibromyalgia diagnosis
Exclusion Criteria:
cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guillaume polidori, Pr
Organizational Affiliation
University of Reims
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
confidential personal data
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Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
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