Back to resultsImpact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
General exercise only
Balance reeducation plus general exercise
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, balance reeducation, pain, function
Eligibility Criteria
Inclusion Criteria:
- must have low back pain longer than three months and age between 40 and 69 years old
Exclusion Criteria:
- balance or neuromuscular disorders, spine surgery, diabetes.
Sites / Locations
- Centro Universitário Fieo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Balance reeducation plus exercise
General exercise only
Arm Description
exercises that challenge postural control are performed in addition to general exercises for stretch and strength of abdominal and paraspinal muscles
general exercise for stretch and strength of paraspinal and abdominal muscles
Outcomes
Primary Outcome Measures
Perceived pain
Pain was measured by an Analogic Visual Scale
Secondary Outcome Measures
Function
Function was measured by the Roland-Morris Questionnaire
Postural Control
Postural control was measured by Functional Reach Test and by posturography
Full Information
NCT ID
NCT01342432
First Posted
April 4, 2011
Last Updated
April 26, 2011
Sponsor
Centro Universitari Fieo
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01342432
Brief Title
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
Official Title
Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centro Universitari Fieo
Collaborators
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.
Detailed Description
Both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. The evolution of the two groups concerning pain level, function and postural control will be compared.
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, balance reeducation, pain, function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance reeducation plus exercise
Arm Type
Experimental
Arm Description
exercises that challenge postural control are performed in addition to general exercises for stretch and strength of abdominal and paraspinal muscles
Arm Title
General exercise only
Arm Type
Other
Arm Description
general exercise for stretch and strength of paraspinal and abdominal muscles
Intervention Type
Other
Intervention Name(s)
General exercise only
Other Intervention Name(s)
control group
Intervention Description
exercises for stretch and strength of paraspinal and abdominal muscles
Intervention Type
Other
Intervention Name(s)
Balance reeducation plus general exercise
Other Intervention Name(s)
balance group, intervention group
Intervention Description
patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles
Primary Outcome Measure Information:
Title
Perceived pain
Description
Pain was measured by an Analogic Visual Scale
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Function
Description
Function was measured by the Roland-Morris Questionnaire
Time Frame
5 weeks
Title
Postural Control
Description
Postural control was measured by Functional Reach Test and by posturography
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must have low back pain longer than three months and age between 40 and 69 years old
Exclusion Criteria:
balance or neuromuscular disorders, spine surgery, diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Bojadsen, PhD
Organizational Affiliation
Centro Universitario Fieo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário Fieo
City
Osasco
State/Province
São Paulo
ZIP/Postal Code
06020-190
Country
Brazil
12. IPD Sharing Statement
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Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
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