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Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by:
Centro Universitari Fieo
ClinicalTrials.gov Identifier:
NCT01342432
First received: April 4, 2011
Last updated: April 26, 2011
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Low Back Pain
 Other: General exercise only
Other: Balance reeducation plus general exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centro Universitari Fieo:

Primary Outcome Measures:
  • Perceived pain [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    Pain was measured by an Analogic Visual Scale


Secondary Outcome Measures:
  • Function [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    Function was measured by the Roland-Morris Questionnaire

  • Postural Control [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    Postural control was measured by Functional Reach Test and by posturography


Enrollment: 35
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: Balance reeducation plus general exercise
patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles
Other Name: balance group, intervention group
General exercise only
general exercise for stretch and strength of paraspinal and abdominal muscles
 Other: General exercise only
exercises for stretch and strength of paraspinal and abdominal muscles
Other Name: control group

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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342432

Locations
Brazil
Centro Universitário Fieo
Osasco, São Paulo, Brazil, 06020-190
Sponsors and Collaborators
Centro Universitari Fieo
University of Sao Paulo
Investigators
Principal Investigator: Thais Bojadsen, PhD Centro Universitario Fieo
  More Information

No publications provided

Responsible Party: Thais Weber Alencar Bojadsen, PhD, Centro Universitário Fieo
ClinicalTrials.gov Identifier: NCT01342432     History of Changes
Other Study ID Numbers: 2008/069241
Study First Received: April 4, 2011
Last Updated: April 26, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Centro Universitari Fieo:
low back pain
balance reeducation
pain
function

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013