Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000141448 |
Date of registration:
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05/02/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effectiveness of a Wii Fit based exercise program in the management of chronic low back pain: a randomized clinical trial.
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Scientific title:
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Effectiveness of a Wii Fit based exercise program in the management of chronic low back pain: a randomized clinical trial. |
Date of first enrolment:
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10/10/2016 |
Target sample size:
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15 |
Recruitment status: |
Recruiting |
URL:
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https://anzctr.org.au/ACTRN12616000141448.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Mr Daniel Vicente
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Address:
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Alcala University.
Av de Leon, 3A, 28805 Alcala de Henares, Madrid
Spain |
Telephone:
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+34696511848 |
Email:
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dfvicentefabregat@outlook.com |
Affiliation:
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Name:
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Mr Daniel Vicente
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Address:
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Alcala University.
Av de Leon, 3A, 28805 Alcala de Henares, Madrid
Spain |
Telephone:
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+34696511848 |
Email:
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dfvicentefabregat@outlook.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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low back pain; low back pain
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Musculoskeletal - Other muscular and skeletal disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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Pain, assessed by 100mm visual analogue scale (VAS)[At the end of the treatment and 3 months later]
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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]
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Secondary Outcome(s)
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Kinesophobia, assessed using Tampa Scale of Kinesophobia (TSK-11 validated to the spanish version)[At the end of the treatment and 3 months later]
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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]
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Pain pressure threshold, assessed using a mechanical algometer[At the end of the treatment and 3 months later]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Alcala University
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Ethics review
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Status: Approved
Approval date:
Contact:
CEIC Hospital Clinico San Carlos
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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