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A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.

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ClinicalTrials.gov Identifier: NCT04128813
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of the Balearic Islands

Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Vertical whole body vibration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: In this clinical trial design strategy, the participants and the investigator do not know which participants have been assigned which interventions so there is a double-blind masking.
Primary Purpose: Treatment
Official Title: A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : January 17, 2020
Estimated Study Completion Date : April 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Vertical whole body vibration platform.
Use of a rotational whole body vibration platform.
Device: Vertical whole body vibration
A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.
Other Name: Rotational whole body vibration

Active Comparator: Rotational whole body vibration platform
Use of a rotational whole body vibration platform.
Device: Vertical whole body vibration
A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.
Other Name: Rotational whole body vibration

No Intervention: Control group
No intervention.



Primary Outcome Measures :
  1. Pressure Pain Thresholds [ Time Frame: 20 minutes ]
    Pressure stimuli were applied on epicondyles and index finger.

  2. Vibration Thresholds [ Time Frame: 20 minutes ]
    Peripheral sensory function was evaluated by measuring vibration thresholds.

  3. 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.

  4. Dynamometer [ Time Frame: 5 minutes. ]
    A back muscle dynamometer was used to measure isometric back muscle strength.

  5. 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.

  6. Gait Task [ Time Frame: 5 minutes. ]
    gait velocity (cm/sec)

  7. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 10 minutes. ]
    Fibromyalgia Impact Questionnaire (FIQ

  8. 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).

  9. 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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia

Exclusion Criteria:

  • History of severe trauma.
  • Severe disease that prevents supporting the program physical load.
  • Pregnancy.
  • Participation in a psychological or physical therapy program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128813


Contacts
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Contact: José Antonio JA Mingorance, PhD +34677602465 josea.mingorance@uib.es

Locations
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Spain
University of Balearic Islands Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07122
Contact: Miquel Roca, PhD, MD    +34 971 173267    mroca@uib.es   
Contact: Margalida Gili, PhD    +34 971 173081    mgili@uib.es   
Sponsors and Collaborators
University of the Balearic Islands
Investigators
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Study Chair: José Antonio JA Mingorance, PhD Professor
Publications of Results:
Other Publications:
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Responsible Party: University of the Balearic Islands
ClinicalTrials.gov Identifier: NCT04128813    
Other Study ID Numbers: IB 2586/15 PI-2
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases