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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Vertical whole body vibration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vertical whole body vibration platform.<br>Use of a rotational whole body vibration platform. | Device: Vertical whole body vibration<br>* A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.<br>* Other names: Rotational whole body vibration;|
| Active Comparator: Rotational whole body vibration platform<br>Use of a rotational whole body vibration platform. | Device: Vertical whole body vibration<br>* A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.<br>* Other names: Rotational whole body vibration;|
| No Intervention: Control group<br>No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Thresholds | Pressure stimuli were applied on epicondyles and index finger. | 20 minutes | 
| Vibration Thresholds | Peripheral sensory function was evaluated by measuring vibration thresholds. | 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. | 6 minutes. | 
| Dynamometer | A back muscle dynamometer was used to measure isometric back muscle strength. | 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. | 1 minute. | 
| Gait Task | gait velocity (cm/sec) | 5 minutes. | 
| Fibromyalgia Impact Questionnaire (FIQ) | Fibromyalgia Impact Questionnaire (FIQ | 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). | 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. | 10 minutes. |