Clinical trial NCT04128813: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 60
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 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pressure Pain Thresholds
timeFrame: 20 minutes
measure: Vibration Thresholds
timeFrame: 20 minutes
measure: Six-minute Walking Test (6MWT)
timeFrame: 6 minutes.
measure: Dynamometer
timeFrame: 5 minutes.
measure: Romberg's Balance Test Modified Version
timeFrame: 1 minute.
measure: Gait Task
timeFrame: 5 minutes.
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 10 minutes.
measure: Visual Analogue Pain Scale (VAS)
timeFrame: 5 minutes.
measure: Perceived Quality of Life Index
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: Professor
name: José Antonio JA Mingorance, PhD
role: STUDY_CHAIR
References:
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.
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.