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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2020-04-17

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.

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Vertical whole body vibration platform.

Use of a rotational whole body vibration platform.

Group Type ACTIVE_COMPARATOR

Vertical whole body vibration

Intervention Type DEVICE

A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.

Rotational whole body vibration platform

Use of a rotational whole body vibration platform.

Group Type ACTIVE_COMPARATOR

Vertical whole body vibration

Intervention Type DEVICE

A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.

Control group

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vertical whole body vibration

A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.

Intervention Type DEVICE

Other Intervention Names

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Rotational whole body vibration

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes