Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor control exercises
Standard exercises
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Motor control, Joint mobilization
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motor control exercises
Standard exercises
Arm Description
One group should perform motor control exercises
the other group should perform standard physiotherapy exercises
Outcomes
Primary Outcome Measures
Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale.
Visual analogic scale
Secondary Outcome Measures
Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.
Roland Morris questionnaire
Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.
diary
Full Information
NCT ID
NCT02633917
First Posted
December 9, 2015
Last Updated
December 14, 2015
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02633917
Brief Title
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
Official Title
Motor Control Exercises vs Standard Exercises in Patients With Unspecific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Motor control, Joint mobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motor control exercises
Arm Type
Experimental
Arm Description
One group should perform motor control exercises
Arm Title
Standard exercises
Arm Type
Active Comparator
Arm Description
the other group should perform standard physiotherapy exercises
Intervention Type
Behavioral
Intervention Name(s)
Motor control exercises
Intervention Description
exercises to strength the lumbar musculature and control the posture
Intervention Type
Behavioral
Intervention Name(s)
Standard exercises
Intervention Description
general exercises
Primary Outcome Measure Information:
Title
Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale.
Description
Visual analogic scale
Time Frame
The day before beginning the intervention, one month and three months after the first ten days of intervention
Secondary Outcome Measure Information:
Title
Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.
Description
Roland Morris questionnaire
Time Frame
The day before beginning the intervention, one month and three months after the first ten days of intervention
Title
Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.
Description
diary
Time Frame
The day before beginning the intervention, one month and three months after the first ten days of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Plaza-Manzano, Ph.D
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
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