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Trial registered on ANZCTR


Registration number
ACTRN12616000141448
Ethics application status
Approved
Date submitted
2/12/2015
Date registered
5/02/2016
Date last updated
20/07/2017
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 288058 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 296927 0
Condition category
Condition code
Musculoskeletal 297168 297168 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293379 0
Lifestyle
Intervention code [2] 293776 0
Treatment: Other
Comparator / control treatment
Control treatment group will complete a conventional exercise program to the treatment of low back pain, based in low back movements like flexion and extension and the stretching of low back muscles. 3 group sessions per week will be made with a duration of 20 minutes, for 4 weeks. Sessions will be done at the hospital, so we can monitor adherence and also we can control that the exercises are done correctly. Sessions will be conducted by a qualified physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 296903 0
Pain, assessed by 100mm visual analogue scale (VAS)
Timepoint [1] 296903 0
At the end of the treatment and 3 months later
Primary outcome [2] 296904 0
Function, assessed using Roland-Morris Dissability Questionnarie (RMDQ) We will use the validated to spanish version
Timepoint [2] 296904 0
At the end of the treatment and 3 months later
Secondary outcome [1] 319667 0
Pain pressure threshold, assessed using a mechanical algometer
Timepoint [1] 319667 0
At the end of the treatment and 3 months later
Secondary outcome [2] 319668 0
Kinesophobia, assessed using Tampa Scale of Kinesophobia (TSK-11 validated to the spanish version)
Timepoint [2] 319668 0
At the end of the treatment and 3 months later
Secondary outcome [3] 319669 0
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)
Timepoint [3] 319669 0
At the end of the treatment and 3 months later

Eligibility
Key inclusion criteria
- Non-specific low back pain diagnosis
- Low back pain for at least 3 months
- Give written informed voluntary consent
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2016
Actual
10/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 7391 0
Spain
State/province [1] 7391 0
Madrid

Funding & Sponsors
Funding source category [1] 292497 0
University
Name [1] 292497 0
Alcala University
Country [1] 292497 0
Spain
Primary sponsor type
University
Name
Alcala University
Address
Campus Universitario - C/ 19,Ctra. Madrid-Barcelona, Km 33,600,28871 Alcala de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 291206 0
None
Name [1] 291206 0
non
Address [1] 291206 0
Country [1] 291206 0
Other collaborator category [1] 278720 0
University
Name [1] 278720 0
Complutense University
Address [1] 278720 0
Plaza Ramon y Cajal
28040 Madrid
Country [1] 278720 0
Spain
Other collaborator category [2] 278721 0
Hospital
Name [2] 278721 0
University Hospital Clinico San Carlos
Address [2] 278721 0
Calle del Prof Martin Lagos, S/N,28040 Madrid
Country [2] 278721 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293963 0
CEIC Hospital Clinico San Carlos
Ethics committee address [1] 293963 0
Ethics committee country [1] 293963 0
Spain
Date submitted for ethics approval [1] 293963 0
Approval date [1] 293963 0
23/07/2015
Ethics approval number [1] 293963 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61926 0
Dr Gustavo Plaza Manzano
Address 61926 0
Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid.

Plaza Ramon y Cajal, Ciudad Universitaria
28040 Madrid
Country 61926 0
Spain
Phone 61926 0
+34913947274
Fax 61926 0
Email 61926 0
gusplaza@ucm.es
Contact person for public queries
Name 61927 0
Daniel Vicente
Address 61927 0
Alcala University.
Av de Leon, 3A, 28805 Alcala de Henares, Madrid
Country 61927 0
Spain
Phone 61927 0
+34696511848
Fax 61927 0
Email 61927 0
dfvicentefabregat@outlook.com
Contact person for scientific queries
Name 61928 0
Daniel Vicente
Address 61928 0
Alcala University.
Av de Leon, 3A, 28805 Alcala de Henares, Madrid
Country 61928 0
Spain
Phone 61928 0
+34696511848
Fax 61928 0
Email 61928 0
dfvicentefabregat@outlook.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.