- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02633917
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
December 14, 2015 updated by: Gustavo Plaza Manzano, Universidad Complutense de Madrid
Motor Control Exercises vs Standard Exercises in Patients With Unspecific Low Back Pain
The purpose of the present study was to evaluate and compare the effects of motor control exercises and standard exercises in the pain, incapacity and medicine intake of subjects with unspecific low-back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eighty-four subjects with unspecific low-back pain were randomly recruited for the present study.
The subjects were randomly allocated into control group (who received one hour of standard physiotherapy exercises every days during ten days) or intervention group (who received one hour of control motor exercises every days during ten days).
One month after finishing these ten days, patients should perform a home-based exercises program during two months (control group performed home-based standard physiotherapy exercises; intervention group performed home-based motor control exercises).
Pain (visual analogic scale), incapacity index (Roland Morris questionnaire) and medicine intake (diary) were evaluated before the intervention, one month and three months after ending the first ten days of intervention.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subjects should be independent to walk
- subjects should have unspecific low back pain during at least the last two months
- subjects should have had at least two recidives of low back pain within the last year
Exclusion Criteria:
- subjects with concomitant pathologies that impede the performance of exercises
- pregnants
- subjects with oncologic pathologies
- subjects with cognitive alterations that impede the understanding of the tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motor control exercises
One group should perform motor control exercises
|
exercises to strength the lumbar musculature and control the posture
|
Active Comparator: Standard exercises
the other group should perform standard physiotherapy exercises
|
general exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale.
Time Frame: The day before beginning the intervention, one month and three months after the first ten days of intervention
|
Visual analogic scale
|
The day before beginning the intervention, one month and three months after the first ten days of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.
Time Frame: The day before beginning the intervention, one month and three months after the first ten days of intervention
|
Roland Morris questionnaire
|
The day before beginning the intervention, one month and three months after the first ten days of intervention
|
Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.
Time Frame: The day before beginning the intervention, one month and three months after the first ten days of intervention
|
diary
|
The day before beginning the intervention, one month and three months after the first ten days of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
December 9, 2015
First Submitted That Met QC Criteria
December 14, 2015
First Posted (Estimate)
December 17, 2015
Study Record Updates
Last Update Posted (Estimate)
December 17, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI 10/374
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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