Use of Whole Body Vibration in Patients With Fibromyalgia

Randomized Controlled Trial of a Therapeutic Intervention Consisting of the Use of Whole Body Vibration in Patients With Fibromyalgia.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03782181

Enrollment

Registered

2018-12-20

Start date

2019-01-07

Completion date

2019-06-28

Last updated

2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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.

Interventions

DEVICEWhole body vibration platform

A neuromuscular treatment using a rotational whole body vibration platform.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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.

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Dynamometer	5 minutes	A back muscle dynamometer was used to measure isometric back muscle strength.
Pressure Pain Thresholds	20 minutes	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	20 minutes	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	30 minutes	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)	6 minutes	The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.
Analysis of the Romberg's Balance Test With the CvMob Software	1 minute	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	5 minutes	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)	5 minutes	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)	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).
Quality of Life Index (QLI)	10 minutes	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.

Countries

Spain

Participant flow

Participants by arm

Arm	Count
Patients Perform Whole Body Vibration Plat 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. Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform.	20
Control Group No intervention arm	20
Total	40

Baseline characteristics

Characteristic	Patients Perform Whole Body Vibration Plat	Control Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	20 Participants	20 Participants	40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants	20 Participants	40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Region of Enrollment Spain	20 participants	20 participants	40 participants
Sex: Female, Male Female	19 Participants	18 Participants	37 Participants
Sex: Female, Male Male	1 Participants	2 Participants	3 Participants
weight	67 kg STANDARD_DEVIATION 7.46	65 kg STANDARD_DEVIATION 5.82	66 kg STANDARD_DEVIATION 6.42

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary

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.

Time frame: 1 minute