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Trial record 40 of 277 for:    quality | "Fibromyalgia"

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

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ClinicalTrials.gov Identifier: NCT03466008
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
François Tubez, Haute École Robert Schuman Libramont

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Whole-Body Cryotherapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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 Name: Usual intervention

No Intervention: Usual treatment arm
usual care



Primary Outcome Measures :
  1. pain status at 1 month from baseline [ Time Frame: change from baseline at one month follow-ups ]
    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 :
  1. pain status at 2 weeks from baseline [ Time Frame: change from baseline at two weeks follow-ups ]
    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

  2. functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire [ Time Frame: chnage from baseline at two weeks follow-ups ]

    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%


  3. functional status : the Oswestry Disability Index (ODI) [ Time Frame: change from baseline at one month follow-ups ]

    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%


  4. functional status : the Disability of the Arm, Shoulder and Hand (DASH) score [ Time Frame: change from baseline at one month follow-ups ]
    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%

  5. functional status : Lower Extremity Functional Scale (LEFS) [ Time Frame: change from baseline at one month follow-ups ]
    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.

  6. health related quality of life (HRQoL) [ Time Frame: change from baseline to one month follow-ups ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Fibromyalgia diagnosis

Exclusion Criteria:

cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466008


Sponsors and Collaborators
Haute École Robert Schuman Libramont
Investigators
Study Director: guillaume polidori, Pr University of Reims

Responsible Party: François Tubez, Physical Therapist, PT, PhD Student, Principal investigator, Haute École Robert Schuman Libramont
ClinicalTrials.gov Identifier: NCT03466008     History of Changes
Other Study ID Numbers: B039201629783
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: confidential personal data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by François Tubez, Haute École Robert Schuman Libramont:
whole body cryotherapy
fibromyalgia
chronic pain
quality of life
perceived health

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases