Condition category
Musculoskeletal Diseases
Date applied
28/11/2007
Date assigned
12/02/2008
Last edited
20/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.afycav.com

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

http://www.unex.es

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

  1. 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.

  2. 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.

Additional files

Editorial Notes