FibromyalgiaNCT03466008
Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
A study testing Whole-Body Cryotherapy in people with Fibromyalgia, run by Haute École Robert Schuman Libramont.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Whole-Body Cryotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia diagnosis
Who cannot join
- cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
About this study
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.
Read the 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).
- Conditions
- Fibromyalgia
- Being tested
- Whole-Body Cryotherapy
- Keywords
- whole body cryotherapy, fibromyalgia, chronic pain, quality of life, perceived health
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body CryotherapyBehavioural
Also called Usual intervention
10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Whole body cryotherapy arm | Experimental | 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. Receives: Behavioral: Whole-Body Cryotherapy |
| Usual treatment arm | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline at one month follow-ups
Secondary outcomes (6)
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
Measured: change from baseline at two weeks follow-ups
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%
Measured: chnage from baseline at two weeks follow-ups
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%
Measured: change from baseline at one month follow-ups
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%
Measured: change from baseline at one month follow-ups
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.
Measured: change from baseline at one month follow-ups
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)
Measured: change from baseline to one month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jan 2017
- Primary completion1 Apr 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute École Robert Schuman Libramont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Tubez, Haute École Robert Schuman Libramont
- Investigators
- guillaume polidori, Pr, Study director, University of Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466008
- Sponsor's protocol ID
- B039201629783
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential personal data
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
- ClinicalTrials.gov ID
- NCT03466008
- Acronym / sponsor ID
- B039201629783
- Conditions
- Fibromyalgia
- Keywords
- whole body cryotherapy, fibromyalgia, chronic pain, quality of life, perceived health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Haute École Robert Schuman LibramontUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
| Arm | Type | Receives |
|---|---|---|
| Whole body cryotherapy arm | Experimental | Behavioral: Whole-Body Cryotherapyintervention 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 treatment arm | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fibromyalgia diagnosis
Key exclusion criteria (1 listed)
- cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body CryotherapyAlso: Usual intervention10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days. | Behavioural | Whole body cryotherapy arm |
Primary outcome
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
6 secondary outcomes
pain status at 2 weeks from baseline
Time frame: change from baseline at two weeks follow-ups
functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire
Time frame: chnage from baseline at two weeks follow-ups
functional status : the Oswestry Disability Index (ODI)
Time frame: change from baseline at one month follow-ups
functional status : the Disability of the Arm, Shoulder and Hand (DASH) score
Time frame: change from baseline at one month follow-ups
functional status : Lower Extremity Functional Scale (LEFS)
Time frame: change from baseline at one month follow-ups
health related quality of life (HRQoL)
Time frame: change from baseline to one month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No. confidential personal data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guillaume polidori, Pr study director
University of Reims
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Cryotherapy in people with Fibromyalgia, run by Haute École Robert Schuman Libramont.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain status at 1 month from baseline (time frame: change from baseline at one month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.