- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342432
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
April 26, 2011 updated by: Centro Universitari Fieo
Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Osasco, São Paulo, Brazil, 06020-190
- Centro Universitário Fieo
-
-
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
40 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Balance reeducation plus exercise
exercises that challenge postural control are performed in addition to general exercises for stretch and strength of abdominal and paraspinal muscles
|
patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles
Other Names:
|
|
Other: General exercise only
general exercise for stretch and strength of paraspinal and abdominal muscles
|
exercises for stretch and strength of paraspinal and abdominal muscles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived pain
Time Frame: 5 weeks
|
Pain was measured by an Analogic Visual Scale
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function
Time Frame: 5 weeks
|
Function was measured by the Roland-Morris Questionnaire
|
5 weeks
|
|
Postural Control
Time Frame: 5 weeks
|
Postural control was measured by Functional Reach Test and by posturography
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thais Bojadsen, PhD, Centro Universitário Fieo
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
January 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
April 4, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (Estimate)
April 27, 2011
Study Record Updates
Last Update Posted (Estimate)
April 27, 2011
Last Update Submitted That Met QC Criteria
April 26, 2011
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/069241
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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