A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedStudy Start
First participant enrolled
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2020
CompletedOctober 17, 2019
October 1, 2019
3 months
October 11, 2019
October 16, 2019
Conditions
Outcome Measures
Primary Outcomes (9)
Pressure Pain Thresholds
Pressure stimuli were applied on epicondyles and index finger.
20 minutes
Vibration Thresholds
Peripheral sensory function was evaluated by measuring vibration thresholds.
20 minutes
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.
6 minutes.
Dynamometer
A back muscle dynamometer was used to measure isometric back muscle strength.
5 minutes.
Romberg's Balance Test Modified Version
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.
1 minute.
Gait Task
gait velocity (cm/sec)
5 minutes.
Fibromyalgia Impact Questionnaire (FIQ)
Fibromyalgia Impact Questionnaire (FIQ
10 minutes.
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).
5 minutes.
Perceived Quality of Life Index
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.
10 minutes.
Study Arms (3)
Vertical whole body vibration platform.
ACTIVE COMPARATORUse of a rotational whole body vibration platform.
Rotational whole body vibration platform
ACTIVE COMPARATORUse of a rotational whole body vibration platform.
Control group
NO INTERVENTIONNo intervention.
Interventions
A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.
Eligibility Criteria
You may qualify if:
- Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia
You may not qualify if:
- History of severe trauma.
- Severe disease that prevents supporting the program physical load.
- Pregnancy.
- Participation in a psychological or physical therapy program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Balearic Islands
Palma de Mallorca, Balearic Islands, 07122, Spain
Related Publications (2)
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.
PMID: 22321155BACKGROUNDAdsuar 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.
PMID: 22327091RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José Antonio JA Mingorance, PhD
Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 16, 2019
Study Start
October 16, 2019
Primary Completion
January 17, 2020
Study Completion
April 17, 2020
Last Updated
October 17, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share