World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616000141448
Date of registration: 05/02/2016
Prospective Registration: Yes
Primary sponsor: Alcala University
Public title: Effectiveness of a Wii Fit based exercise program in the management of chronic low back pain: a randomized clinical trial.
Scientific title: Effectiveness of a Wii Fit based exercise program in the management of chronic low back pain: a randomized clinical trial.
Date of first enrolment: 10/10/2016
Target sample size: 15
Recruitment status: Recruiting
URL:  https://anzctr.org.au/ACTRN12616000141448.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial;  
Phase: 
Countries of recruitment
Spain
Contacts
Name: Mr Daniel Vicente   
Address:  Alcala University. Av de Leon, 3A, 28805 Alcala de Henares, Madrid Spain
Telephone: +34696511848
Email: dfvicentefabregat@outlook.com
Affiliation: 
Name: Mr Daniel Vicente   
Address:  Alcala University. Av de Leon, 3A, 28805 Alcala de Henares, Madrid Spain
Telephone: +34696511848
Email: dfvicentefabregat@outlook.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: - Non-specific low back pain diagnosis
- Low back pain for at least 3 months
- Give written informed voluntary consent

Exclusion criteria: - Non-mechanical low back pain diagnosis
- Any spinal surgery
- Abdominal surgery within the last 12 months
- Evidence of Cauda equina compression
- Systemic illness
- Radiculopathy or nerve root compression
- Pysichiatric treatment


Age minimum: 20 Years
Age maximum: 65 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
low back pain;
low back pain
Musculoskeletal - Other muscular and skeletal disorders
Intervention(s)
We'll suggest two different exercise programs to the treatment of low back pain. Wii fit program is based in some Wii Fit games such as warrior pose, ski slalom or single leg lift. To play this games you need to do some movements like flexion, extension and stretching of the low back muscles. 2 individual sessions per week will be made with a duration of 20 minutes, for 4 weeks. Sessions are conducted by a qualified physiotherapist. The program will be done at the hospital, so we can monitor adherence and also we can control that the exercises are done correctly.
Primary Outcome(s)
Pain, assessed by 100mm visual analogue scale (VAS)[At the end of the treatment and 3 months later]
Function, assessed using Roland-Morris Dissability Questionnarie (RMDQ) We will use the validated to spanish version[At the end of the treatment and 3 months later]
Secondary Outcome(s)
Kinesophobia, assessed using Tampa Scale of Kinesophobia (TSK-11 validated to the spanish version)[At the end of the treatment and 3 months later]
Global perceived effect of treatment, assessed using an 11- point scale that ranged from -5 (vastly worse) through 0
(no change) to +5 (completely recovered)
[At the end of the treatment and 3 months later]
Pain pressure threshold, assessed using a mechanical algometer[At the end of the treatment and 3 months later]
Secondary ID(s)
Nil known
Source(s) of Monetary Support
Alcala University
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
CEIC Hospital Clinico San Carlos
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history