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

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vertical whole body vibration
Sponsored by
University of the Balearic Islands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Balearic IslandsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Vertical whole body vibration platform.

Rotational whole body vibration platform

Control group

Arm Description

Use of a rotational whole body vibration platform.

Use of a rotational whole body vibration platform.

No intervention.

Outcomes

Primary Outcome Measures

Pressure Pain Thresholds
Pressure stimuli were applied on epicondyles and index finger.
Vibration Thresholds
Peripheral sensory function was evaluated by measuring vibration thresholds.
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.
Dynamometer
A back muscle dynamometer was used to measure isometric back muscle strength.
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.
Gait Task
gait velocity (cm/sec)
Fibromyalgia Impact Questionnaire (FIQ)
Fibromyalgia Impact Questionnaire (FIQ
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).
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.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2019
Last Updated
October 16, 2019
Sponsor
University of the Balearic Islands
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1. Study Identification

Unique Protocol Identification Number
NCT04128813
Brief Title
A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
Official Title
A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Anticipated)
Study Completion Date
April 17, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Balearic Islands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vertical whole body vibration platform.
Arm Type
Active Comparator
Arm Description
Use of a rotational whole body vibration platform.
Arm Title
Rotational whole body vibration platform
Arm Type
Active Comparator
Arm Description
Use of a rotational whole body vibration platform.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Device
Intervention Name(s)
Vertical whole body vibration
Other Intervention Name(s)
Rotational whole body vibration
Intervention Description
A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.
Primary Outcome Measure Information:
Title
Pressure Pain Thresholds
Description
Pressure stimuli were applied on epicondyles and index finger.
Time Frame
20 minutes
Title
Vibration Thresholds
Description
Peripheral sensory function was evaluated by measuring vibration thresholds.
Time Frame
20 minutes
Title
Six-minute Walking Test (6MWT)
Description
The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.
Time Frame
6 minutes.
Title
Dynamometer
Description
A back muscle dynamometer was used to measure isometric back muscle strength.
Time Frame
5 minutes.
Title
Romberg's Balance Test Modified Version
Description
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.
Time Frame
1 minute.
Title
Gait Task
Description
gait velocity (cm/sec)
Time Frame
5 minutes.
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
Fibromyalgia Impact Questionnaire (FIQ
Time Frame
10 minutes.
Title
Visual Analogue Pain Scale (VAS)
Description
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).
Time Frame
5 minutes.
Title
Perceived Quality of Life Index
Description
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.
Time Frame
10 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Antonio JA Mingorance, PhD
Phone
+34677602465
Email
josea.mingorance@uib.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Antonio JA Mingorance, PhD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
University of Balearic Islands
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07122
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miquel Roca, PhD, MD
Phone
+34 971 173267
Email
mroca@uib.es
First Name & Middle Initial & Last Name & Degree
Margalida Gili, PhD
Phone
+34 971 173081
Email
mgili@uib.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22321155
Citation
Sanudo B, de Hoyo M, Carrasco L, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, McVeigh JG. Effect of whole-body vibration exercise on balance in women with fibromyalgia syndrome: a randomized controlled trial. J Altern Complement Med. 2012 Feb;18(2):158-64. doi: 10.1089/acm.2010.0881. Epub 2012 Feb 9.
Results Reference
background
PubMed Identifier
22327091
Citation
Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body vibration improves the single-leg stance static balance in women with fibromyalgia: a randomized controlled trial. J Sports Med Phys Fitness. 2012 Feb;52(1):85-91.
Results Reference
result

Learn more about this trial

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

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