Clinical trial NCT03782181: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pressure Pain Thresholds
timeFrame: 20 minutes
measure: Vibration Thresholds
timeFrame: 20 minutes
measure: Berg Scale
timeFrame: 30 minutes
measure: Six-minute Walking Test (6MWT)
timeFrame: 6 minutes
measure: Dynamometer
timeFrame: 5 minutes
measure: Analysis of the Romberg's Balance Test With the CvMob Software
timeFrame: 1 minute
measure: Gait Task
timeFrame: 5 minutes
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 5 minutes
measure: Visual Analogue Pain Scale (VAS)
timeFrame: 5 minutes
measure: Quality of Life Index (QLI)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: University of Balearic Islands
state: Balearic Islands
Study officials:
affiliation: Balearic Islands University
name: José A Mingorance, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.