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

October 16, 2019 updated by: University of the Balearic Islands
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07122
        • Recruiting
        • University of Balearic Islands
        • Contact:
          • Miquel Roca, PhD, MD
          • Phone Number: +34 971 173267
          • Email: mroca@uib.es
        • Contact:
          • Margalida Gili, PhD
          • Phone Number: +34 971 173081
          • Email: mgili@uib.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention.
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 Names:
  • 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 Names:
  • Rotational whole body vibration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Balearic Islands

Investigators

  • Study Chair: José Antonio JA Mingorance, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2019

Primary Completion (Anticipated)

January 17, 2020

Study Completion (Anticipated)

April 17, 2020

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB 2586/15 PI-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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