Contact information
Type
Scientific
Primary contact
Prof Narcis Gusi
ORCID ID
Contact details
Faculty of Sports Sciences
University of Extremadura
Caceres
10071
Spain
+34 927 257460
ngusi@unex.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11/05
Study information
Scientific title
Acronym
EVFEO/11/05
Study hypothesis
1. Whole-body vibration exercise is effective in improving muscular strength in lower limbs and balance in women with fibromyalgia
2. Whole-body vibration exercise is effective in improving health related quality of life in women with fibromyalgia
3. Whole-body vibration is a cost-effective alternative compared to usual health care
Ethics approval
Approved by the Biomedic Ethical Committee of the University of Extremadura on 12/06/2005; reference number 11/05 (academic research funded in 2007).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Fibromyalgia
Intervention
Intervention group: Three sessions of whole-body vibration per week. Each session consisted of 6 repetitions at 12.6 HZ of whole-body vibration on reciprocal vibrating platform (Galileo 2000, Novotec. Germany). The feet of subject will be aligned perpendicular to usual use (this is a new technique). The time spent in each repetition will be increased 15 seconds every month from 30 second to 1 minute.
Control group: Usual care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following will be assessed at baseline and 3 months:
1. Balance (Fall risk and postural stability) measured by Biodex Balance
2. Neuromuscular function (isokinetic measurements with surface electromyography measurements) measured by System-3 Biodex Dynamometer and MP100 Biopac
3. Fear to Fall Questionnaire (FES-I)
4. Health related Quality of life:
4.1. EuroQol EQ-5D Instrument (utility index)
4.2. Fibromyalgia Impact Questionnaire
4.3. 15-D instrument (utility index)
4.4. 36-item Short Form health survey (SF-36) (utility index)
5. Health system and societal costs
6. Pain threshold measured by algometer
Secondary outcome measures
The following will be assessed at baseline and 3 months:
1. Hand-grip
2. Percentage of fat
3. Visual Analogue Scale for pain (0-10)
4. Visual Analogue Scale for general health (attached to EuroQOL 5D [EQ-5D])
Overall trial start date
30/11/2007
Overall trial end date
30/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatology criteria
2. Older than 35 years
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
50
Participant exclusion criteria
1. Contraindications to physical exercise
2. Other physical or psychological therapies different from usual care in the National Health Service (outpatient clinic)
3. Cognitive disease
Recruitment start date
30/11/2007
Recruitment end date
30/05/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Faculty of Sports Sciences
Caceres
10071
Spain
Sponsor information
Organisation
University of Extremadura (Spain)
Sponsor details
Avda Elvas s/n
Badajoz
06071
Spain
+34 92 428 93 05
vicein@unex.es
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health & Dependence Department and Young & Sports Department of Junta de Extremadura (ref: 118/06) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Extremadura (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21749265
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22327091
Publication citations
-
Results
Olivares PR, Gusi N, Parraca JA, Adsuar JC, Del Pozo-Cruz B, Tilting Whole Body Vibration improves quality of life in women with fibromyalgia: a randomized controlled trial., J Altern Complement Med, 2011, 17, 8, 723-728, doi: 10.1089/acm.2010.0296.
-
Results
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, 52, 1, 85-91.