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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
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 9, 2015
    Last Updated
    December 14, 2015
    Sponsor
    Universidad Complutense de Madrid
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    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

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    Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain

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