Condition category
Musculoskeletal Diseases
Date applied
12/08/2009
Date assigned
14/10/2009
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Narcis Gusi

ORCID ID

Contact details

Faculty of Sport Sciences
Avda Universidad s/n
Caceres
10071
Spain
+34 92 725 74 60
ngusi@unex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CEBP42/2006

Study information

Scientific title

Cost-effectiveness of exercise programmes to prevent low back pain and falls (I): a blinded randomised controlled trial of low-frequency vibratory exercise

Acronym

Vibrobackpain

Study hypothesis

1. Low-frequency vibratory exercise will prevent moderate low-back pain
2. Low-frequency vibratory exercise will reduce the risk of falling in patients with low back pain
3. Low-frequency vibratory exercise is a cost-effective addition to usual care in patients with low back pain

Ethics approval

Biomedical Ethical Committee of the University of Extremadura approved on the 10th October 2006 (ref: 42/2006)

Study design

Blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic low back pain

Intervention

The participants will be randomly assigned to intervention or control group by a random table built by computer:
1. Interventional group: Three-month progressive whole body vibration (WBV) programme set at 20 HZ , applied twice a week
2. Control group: Care as usual
The treatment will last three months and patients will be followed up for one year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at baseline, three months, and one year:
1. Socio-sanitary costs
2. Functional and psychological disability in CLBP (using Roland-Morris questionnaire and Fear-Avoidance Beliefs Questionnaire [FABQ])
3. Health-related quality of life (using the EuroQoL questionnaire [EQ-5D]) and their utilities to health economic analyses
4. Fitness and neuromuscular function (using the tests of Sorensen, Ito-Shirado, straight leg raising and balance with Biodex Balance Platform)

Secondary outcome measures

Measured at baseline, three months, and one year:
1. Health related quality of life measured using the 36-item short form health survey (SF36) and the 15-D instrument
2. Grade of satisfaction with programme
3. The Start Back Tool (SBST) instrument to evaluate unspecified low back pain

Overall trial start date

01/09/2009

Overall trial end date

20/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with chronic low-back pain (CLBP) without major neurological alterations
2. Patient assessed by Pain Unit in Extremadura
3. Diagnosis of chronic low back pain (CLBP) according to "International Classification of Diseases, Ninth Revision (ICD-9)"
4. CLBP episodes for more than six months
5. Informed consent
6. Aged 40 to 70 years, male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 patients

Participant exclusion criteria

1. Other major disease
2. Regular physical activity more than one day a week in the last 5 years
3. Any drug intake that may affect balance significantly - to avoid external influences

Recruitment start date

01/09/2009

Recruitment end date

20/01/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Faculty of Sport 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

Government of Extremadura and European Social Funds (Spain) (ref: PRI070B093)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Goverment of Spain (Spain) - grant for a university research-professor student (FPU) (ref: AP2008-02211)

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

Publication citations

Additional files

Editorial Notes