Cost-effectiveness of exercise programmes to prevent low back pain and falls (I): low-frequency vibratory exercise
| ISRCTN | ISRCTN31946666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31946666 |
| Secondary identifying numbers | CEBP42/2006 |
- Submission date
- 12/08/2009
- Registration date
- 14/10/2009
- Last edited
- 21/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Narcis Gusi
Scientific
Scientific
Faculty of Sport Sciences
Avda Universidad s/n
Caceres
10071
Spain
| Phone | +34 92 725 74 60 |
|---|---|
| ngusi@unex.es |
Study information
| Study design | Blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | Vibrobackpain |
| Study objectives | 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(s) | Biomedical Ethical Committee of the University of Extremadura approved on the 10th October 2006 (ref: 42/2006) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2009 |
| Completion date | 20/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 patients |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 20/01/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Faculty of Sport Sciences
Caceres
10071
Spain
10071
Spain
Sponsor information
University of Extremadura (Spain)
University/education
University/education
Avda Elvas s/n
Badajoz
06071
Spain
| Phone | +34 92 428 93 05 |
|---|---|
| vicein@unex.es | |
| Website | http://www.unex.es |
"ROR" |
https://ror.org/0174shg90 |
Funders
Funder type
Government
Government of Extremadura and European Social Funds (Spain) (ref: PRI070B093)
No information available
Goverment of Spain (Spain) - grant for a university research-professor student (FPU) (ref: AP2008-02211)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | 21/08/2019 | Yes | No |
Editorial Notes
21/08/2019: Publication reference and total final enrolment added.
