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 measure
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 (if study stopped)
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
Total final enrolment
50
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
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
Basic results (scientific)
Publication list
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21687923 (added 21/08/2019)