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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
Haute École Robert Schuman Libramont
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 2, 2018
    Last Updated
    March 8, 2018
    Sponsor
    Haute École Robert Schuman Libramont
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    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

    Learn more about this trial

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

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