Fibromyalgia
Conditions
Keywords
whole body cryotherapy, fibromyalgia, chronic pain, quality of life, perceived health
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).
Interventions
BEHAVIORALWhole-Body Cryotherapy
10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days.
Sponsors
Haute École Robert Schuman Libramont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Fibromyalgia diagnosis
Exclusion criteria
cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain status at 1 month from baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire | 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% |
| functional status : the Oswestry Disability Index (ODI) | 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% |
| pain status at 2 weeks from baseline | 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 |
| functional status : Lower Extremity Functional Scale (LEFS) | 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. |
| health related quality of life (HRQoL) | 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) |
| functional status : the Disability of the Arm, Shoulder and Hand (DASH) score | 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% |
Outcome results
None listed