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

U

University of the Balearic Islands

Status

Unknown

Conditions

Fibromyalgia

Treatments

Device: Vertical whole body vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT04128813
IB 2586/15 PI-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Vertical whole body vibration platform.
Active Comparator group
Description:
Use of a rotational whole body vibration platform.
Treatment:
Device: Vertical whole body vibration
Rotational whole body vibration platform
Active Comparator group
Description:
Use of a rotational whole body vibration platform.
Treatment:
Device: Vertical whole body vibration
Control group
No Intervention group
Description:
No intervention.

Trial contacts and locations

1

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Central trial contact

José Antonio JA Mingorance, PhD

Data sourced from clinicaltrials.gov

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