A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
- Conditions
- Fibromyalgia
- Interventions
- Device: Vertical whole body vibration
- Registration Number
- NCT04128813
- Lead Sponsor
- University of the Balearic Islands
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
-Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia
- History of severe trauma.
- Severe disease that prevents supporting the program physical load.
- Pregnancy.
- Participation in a psychological or physical therapy program.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vertical whole body vibration platform. Vertical whole body vibration Use of a rotational whole body vibration platform. Rotational whole body vibration platform Vertical whole body vibration Use of a rotational whole body vibration platform.
- Primary Outcome Measures
Name Time Method Romberg's Balance Test Modified Version 1 minute. 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 5 minutes. gait velocity (cm/sec)
Vibration Thresholds 20 minutes Peripheral sensory function was evaluated by measuring vibration thresholds.
Pressure Pain Thresholds 20 minutes Pressure stimuli were applied on epicondyles and index finger.
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.
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).
Fibromyalgia Impact Questionnaire (FIQ) 10 minutes. Fibromyalgia Impact Questionnaire (FIQ
Dynamometer 5 minutes. A back muscle dynamometer was used to measure isometric back muscle strength.
Perceived Quality of Life Index 10 minutes. 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
Name Time Method
Trial Locations
- Locations (1)
University of Balearic Islands
🇪🇸Palma de Mallorca, Balearic Islands, Spain