Fibromyalgia Clinical Trial
Official title:
Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Verified date | March 2018 |
Source | Haute École Robert Schuman Libramont |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Haute École Robert Schuman Libramont |
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 |
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