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Use of Whole Body Vibration in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Whole body vibration platform
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:

  • Patients with FM were included in the study if they fulfilled the 1990 classification criteria of the American College of Rheumatology for fibromyalgia.
  • Pain-free volunteers were included if they did not present pain symptoms or some type of treatment in any part of the body during the previous 12 months.

Exclusion Criteria:

  • Participants were excluded from the study if they had not signed the informed consent or if they reported any other musculoskeletal disorder rather than patients with FM, any neurological disorder or had previous spinal fusion surgery or spinal cord stimulation.

Sites / Locations

  • University of Balearic Islands

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Whole body vibration plat

Control group

Arm Description

An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.

No intervention arm

Outcomes

Primary Outcome Measures

Pressure Pain Thresholds
Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.
Vibration Thresholds
Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.
Berg Scale
This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.
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.
Analysis of the Romberg's Balance Test With the CvMob Software
The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.
Gait Task
Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.
Fibromyalgia Impact Questionnaire (FIQ)
The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
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).
Quality of Life Index (QLI)
The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2018
Last Updated
January 29, 2020
Sponsor
University of the Balearic Islands
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1. Study Identification

Unique Protocol Identification Number
NCT03782181
Brief Title
Use of Whole Body Vibration in Patients With Fibromyalgia
Official Title
Randomized Controlled Trial of a Therapeutic Intervention Consisting of the Use of Whole Body Vibration in Patients With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

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 evaluate the efficacy of a 3-month program consisted of the use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether this intervention would be effective to short and medium-term improvement of symptoms in these patients.
Detailed Description
This was a single blind randomized controlled trial. Forty patients of FM group were assigned randomly to 2 study groups: 20 patients will be part of the experimental group (EG) that will perform a neuromuscular treatment using the vertical 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 took place between January and Juny 2019. Two 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,two groups of participants receive different interventions. One group receives a training with a whole body vibration plattform and the other 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
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration plat
Arm Type
Active Comparator
Arm Description
An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention arm
Intervention Type
Device
Intervention Name(s)
Whole body vibration platform
Intervention Description
A neuromuscular treatment using a rotational whole body vibration platform.
Primary Outcome Measure Information:
Title
Pressure Pain Thresholds
Description
Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.
Time Frame
20 minutes
Title
Vibration Thresholds
Description
Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.
Time Frame
20 minutes
Title
Berg Scale
Description
This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.
Time Frame
30 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
Analysis of the Romberg's Balance Test With the CvMob Software
Description
The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.
Time Frame
1 minute
Title
Gait Task
Description
Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.
Time Frame
5 minutes
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
Time Frame
5 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
Quality of Life Index (QLI)
Description
The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.
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: Patients with FM were included in the study if they fulfilled the 1990 classification criteria of the American College of Rheumatology for fibromyalgia. Pain-free volunteers were included if they did not present pain symptoms or some type of treatment in any part of the body during the previous 12 months. Exclusion Criteria: Participants were excluded from the study if they had not signed the informed consent or if they reported any other musculoskeletal disorder rather than patients with FM, any neurological disorder or had previous spinal fusion surgery or spinal cord stimulation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José A Mingorance, PhD
Organizational Affiliation
Balearic Islands University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Balearic Islands
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07122
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
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
result

Learn more about this trial

Use of Whole Body Vibration in Patients With Fibromyalgia

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