FibromyalgiaNCT03782181
Use of Whole Body Vibration in Patients With Fibromyalgia
A study testing Whole body vibration platform in people with Fibromyalgia, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the efficacy of a 3-month program consisted of the use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether this intervention would be effective to short and medium-term improvement of symptoms in these patients. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Whole body vibration platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2019to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with FM were included in the study if they fulfilled the 1990 classification criteria of the American College of Rheumatology for fibromyalgia.
- Pain-free volunteers were included if they did not present pain symptoms or some type of treatment in any part of the body during the previous 12 months.
Who cannot join
- Participants were excluded from the study if they had not signed the informed consent or if they reported any other musculoskeletal disorder rather than patients with FM, any neurological disorder or had previous spinal fusion surgery or spinal cord stimulation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: Randomized Controlled Trial of a Therapeutic Intervention Consisting of the Use of Whole Body Vibration in Patients With Fibromyalgia.
The objective of this study is to evaluate the efficacy of a 3-month program consisted of the use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether this intervention would be effective to short and medium-term improvement of symptoms in these patients.
Read the detailed description
This was a single blind randomized controlled trial. Forty patients of FM group were assigned randomly to 2 study groups: 20 patients will be part of the experimental group (EG) that will perform a neuromuscular treatment using the vertical whole body vibration platform and another 20 will constitute the control group (CG). All these subjects will sign the corresponding informed consent for their participation in the study, according to the ethical criteria established in the Helsinki Declaration. The study took place between January and Juny 2019. Two groups of variables were analyzed in the present study three times: before, after and follow-up after three months of the intervention.
- Conditions
- Fibromyalgia
- Being tested
- Whole body vibration platform
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration platformDevice
A neuromuscular treatment using a rotational whole body vibration platform.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration plat | Active comparator | An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence. Receives: Device: Whole body vibration platform |
| Control group | No intervention | No intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Thresholds
Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.
Measured: 20 minutes
Vibration Thresholds
Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.
Measured: 20 minutes
Berg Scale
This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.
Measured: 30 minutes
Six-minute Walking Test (6MWT)
The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.
Measured: 6 minutes
Dynamometer
A back muscle dynamometer was used to measure isometric back muscle strength.
Measured: 5 minutes
Analysis of the Romberg's Balance Test With the CvMob Software
The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.
Measured: 1 minute
Gait Task
Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.
Measured: 5 minutes
Fibromyalgia Impact Questionnaire (FIQ)
The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
Measured: 5 minutes
Visual Analogue Pain Scale (VAS)
Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).
Measured: 5 minutes
Quality of Life Index (QLI)
The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start7 Jan 2019
- Primary completion25 Mar 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this clinical,two groups of participants receive different interventions. One group receives a training with a whole body vibration plattform and the other is the control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José A Mingorance, PhD, Principal investigator, Balearic Islands University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782181
- Sponsor's protocol ID
- IB 2586/15 PI
- Status last verified
- Jan 2020
- First submitted
- 16 Dec 2018
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body vibration improves the single-leg stance static balance in women with fibromyalgia: a randomized controlled trial. J Sports Med Phys Fitness. 2012 Feb;52(1):85-91.
PubMed 22327091Sanudo B, de Hoyo M, Carrasco L, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, McVeigh JG. Effect of whole-body vibration exercise on balance in women with fibromyalgia syndrome: a randomized controlled trial. J Altern Complement Med. 2012 Feb;18(2):158-64. doi: 10.1089/acm.2010.0881. Epub 2012 Feb 9.
PubMed 22321155
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Therapeutic Intervention Consisting of the Use of Whole Body Vibration in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT03782181
- Acronym / sponsor ID
- IB 2586/15 PI
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of a 3-month program consisted of the use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether this intervention would be effective to short and medium-term improvement of symptoms in these patients.
Detailed description
This was a single blind randomized controlled trial. Forty patients of FM group were assigned randomly to 2 study groups: 20 patients will be part of the experimental group (EG) that will perform a neuromuscular treatment using the vertical whole body vibration platform and another 20 will constitute the control group (CG). All these subjects will sign the corresponding informed consent for their participation in the study, according to the ethical criteria established in the Helsinki Declaration. The study took place between January and Juny 2019. Two groups of variables were analyzed in the present study three times: before, after and follow-up after three months of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In this clinical,two groups of participants receive different interventions. One group receives a training with a whole body vibration plattform and the other is the control group.
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration plat | Active comparator | Device: Whole body vibration platformAn arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence. |
| Control group | No intervention | –No intervention arm |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with FM were included in the study if they fulfilled the 1990 classification criteria of the American College of Rheumatology for fibromyalgia.
- Pain-free volunteers were included if they did not present pain symptoms or some type of treatment in any part of the body during the previous 12 months.
Key exclusion criteria (1 listed)
- Participants were excluded from the study if they had not signed the informed consent or if they reported any other musculoskeletal disorder rather than patients with FM, any neurological disorder or had previous spinal fusion surgery or spinal cord stimulation.
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 vibration platformA neuromuscular treatment using a rotational whole body vibration platform. | Device | Whole body vibration plat |
Primary outcome
Pressure Pain Thresholds
Time frame: 20 minutes
Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.
Vibration Thresholds
Time frame: 20 minutes
Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.
Berg Scale
Time frame: 30 minutes
This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.
Six-minute Walking Test (6MWT)
Time frame: 6 minutes
The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.
Dynamometer
Time frame: 5 minutes
A back muscle dynamometer was used to measure isometric back muscle strength.
Analysis of the Romberg's Balance Test With the CvMob Software
Time frame: 1 minute
The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.
Gait Task
Time frame: 5 minutes
Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 5 minutes
The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
Visual Analogue Pain Scale (VAS)
Time frame: 5 minutes
Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).
Quality of Life Index (QLI)
Time frame: 10 minutes
The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22327091Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body vibration improves the single-leg stance static balance in women with fibromyalgia: a randomized controlled trial. J Sports Med Phys Fitness. 2012 Feb;52(1):85-91.
- Results publication: PubMed 22321155Sanudo B, de Hoyo M, Carrasco L, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, McVeigh JG. Effect of whole-body vibration exercise on balance in women with fibromyalgia syndrome: a randomized controlled trial. J Altern Complement Med. 2012 Feb;18(2):158-64. doi: 10.1089/acm.2010.0881. Epub 2012 Feb 9.
- Individual participant dataSharing planned: No
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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.
José A Mingorance, PhD principal investigator
Balearic Islands University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration platform in people with Fibromyalgia, run by University of the Balearic Islands at 1 site in Spain.
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 2 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pressure Pain Thresholds (time frame: 20 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782181, which also lists 2 linked publications.
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 13 Feb 2020.