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
Protocol serial number	CEBP42/2006
Sponsor	University of Extremadura (Spain)
Funders	Government of Extremadura and European Social Funds (Spain) (ref: PRI070B093), Goverment of Spain (Spain) - grant for a university research-professor student (FPU) (ref: AP2008-02211)

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

Faculty of Sport Sciences
Avda Universidad s/n
Caceres
10071
Spain

Phone	+34 92 725 74 60
Email	ngusi@unex.es

Study information

Primary study design	Interventional
Study design	Blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	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
Completion date	20/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/08/2019: Publication reference and total final enrolment added.