FibromyalgiaNCT04128813
A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
A study testing Vertical whole body vibration 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 compare the effectiveness of two types of body vibration platform, one vertical and one rotational, through a 12-week training in patients with fibromyalgia. 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?
- Vertical whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Oct 2019to 17 Apr 2020
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia
Who cannot join
- History of severe trauma.
- Severe disease that prevents supporting the program physical load.
- Pregnancy.
- Participation in a psychological or physical therapy program.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
Miquel Roca, PhD, MD, +34 971 173267, mroca@uib.es
Margalida Gili, PhD, +34 971 173081, mgili@uib.es
About this study
The objective of this study is to compare the effectiveness of two types of body vibration platform, one vertical and one rotational, through a 12-week training in patients with fibromyalgia.
Read the detailed description
This is a single blind randomized controlled trial. Sixty patients of FM will be assigned randomly to 3 study groups: 20 patients will be part of the vertical whole body vibration experimental group in the EG1, that will perform a neuromuscular treatment using the vertical whole body vibration platform, another 20 will constitute the rotational whole body vibration experimental group in the EG2, that will perform a neuromuscular treatment using the rotational 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 will take place between January and December 2016. Three 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
- Vertical whole body vibration
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical whole body vibrationDevice
Also called Rotational whole body vibration
A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.
| Study group | Role | What they receive |
|---|---|---|
| Vertical whole body vibration platform. | Active comparator | Use of a rotational whole body vibration platform. Receives: Device: Vertical whole body vibration |
| Rotational whole body vibration platform | Active comparator | Use of a rotational whole body vibration platform. Receives: Device: Vertical whole body vibration |
| Control group | No intervention | No intervention. |
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 epicondyles and index finger.
Measured: 20 minutes
Vibration Thresholds
Peripheral sensory function was evaluated by measuring vibration thresholds.
Measured: 20 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.
Romberg's Balance Test Modified Version
In the present study, we analyzed the oscillatory body movements during the test performance. Participants were situated below a cam situated above the ground and regulated to be placed at a mean distance of 50 cm. from the participant's head. They were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute.
Measured: 1 minute.
Gait Task
gait velocity (cm/sec)
Measured: 5 minutes.
Fibromyalgia Impact Questionnaire (FIQ)
Fibromyalgia Impact Questionnaire (FIQ
Measured: 10 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.
Perceived Quality of Life Index
The Quality of Life Index (QLI-Sp) is a self-report questionnaire that measures perceived health-related quality of life that includes 10 items or domains: physical wellbeing, psychological/emotional well-being, selfcare and independent functioning, occupational functioning,interpersonal functioning, social-emotional support, community and services support, personal fulfilment, spiritual fulfilment, and overall quality of life.
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 posted16 Oct 2019
- Study start16 Oct 2019
- Primary completion17 Jan 2020 (estimated)
- Study completion17 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 trial design, three groups of participants receive different interventions. One group receives a training with a vertical whole body vibration plattform, another group receives a training with a rotational whole body vibration platform and the third one is the control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Antonio JA Mingorance, PhD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128813
- Sponsor's protocol ID
- IB 2586/15 PI-2
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanudo 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 22321155Adsuar 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 22327091
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04128813
- Acronym / sponsor ID
- IB 2586/15 PI-2
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 17 Jan 2020 (estimated)
- Study completion
- 17 Apr 2020 (estimated)
- First posted
- 16 Oct 2019 (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.
The objective of this study is to compare the effectiveness of two types of body vibration platform, one vertical and one rotational, through a 12-week training in patients with fibromyalgia.
Detailed description
This is a single blind randomized controlled trial. Sixty patients of FM will be assigned randomly to 3 study groups: 20 patients will be part of the vertical whole body vibration experimental group in the EG1, that will perform a neuromuscular treatment using the vertical whole body vibration platform, another 20 will constitute the rotational whole body vibration experimental group in the EG2, that will perform a neuromuscular treatment using the rotational 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 will take place between January and December 2016. Three 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
- 3
- Model description
- In this clinical trial design, three groups of participants receive different interventions. One group receives a training with a vertical whole body vibration plattform, another group receives a training with a rotational whole body vibration platform and the third one is the control group.
| Arm | Type | Receives |
|---|---|---|
| Vertical whole body vibration platform. | Active comparator | Device: Vertical whole body vibrationUse of a rotational whole body vibration platform. |
| Rotational whole body vibration platform | Active comparator | Device: Vertical whole body vibrationUse of a rotational whole body vibration platform. |
| Control group | No intervention | –No intervention. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia
Key exclusion criteria (4 listed)
- History of severe trauma.
- Severe disease that prevents supporting the program physical load.
- Pregnancy.
- Participation in a psychological or physical therapy program.
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 |
|---|---|---|
| Vertical whole body vibrationAlso: Rotational whole body vibrationA neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform. | Device | Rotational whole body vibration platform, Vertical whole body vibration platform. |
Primary outcome
Pressure Pain Thresholds
Time frame: 20 minutes
Pressure stimuli were applied on epicondyles and index finger.
Vibration Thresholds
Time frame: 20 minutes
Peripheral sensory function was evaluated by measuring vibration thresholds.
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.
Romberg's Balance Test Modified Version
Time frame: 1 minute.
In the present study, we analyzed the oscillatory body movements during the test performance. Participants were situated below a cam situated above the ground and regulated to be placed at a mean distance of 50 cm. from the participant's head. They were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute.
Gait Task
Time frame: 5 minutes.
gait velocity (cm/sec)
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 10 minutes.
Fibromyalgia Impact Questionnaire (FIQ
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).
Perceived Quality of Life Index
Time frame: 10 minutes.
The Quality of Life Index (QLI-Sp) is a self-report questionnaire that measures perceived health-related quality of life that includes 10 items or domains: physical wellbeing, psychological/emotional well-being, selfcare and independent functioning, occupational functioning,interpersonal functioning, social-emotional support, community and services support, personal fulfilment, spiritual fulfilment, and overall quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: 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.
- 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.
- 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 Antonio JA Mingorance, PhD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical whole body vibration 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Antonio JA Mingorance, PhD (+34677602465, josea.mingorance@uib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Thresholds (time frame: 20 minutes). The study lists 9 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 NCT04128813, 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 17 Oct 2019.