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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342432
• Other study ID #: 2008/069241
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: April 26, 2011
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: Centro Universitari Fieo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• General exercise only
exercises for stretch and strength of paraspinal and abdominal muscles
• Balance reeducation plus general exercise
patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles

Locations

Country	Name	City	State
Brazil	Centro Universitário Fieo	Osasco	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Centro Universitari Fieo	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived pain	Pain was measured by an Analogic Visual Scale	5 weeks	Yes
Secondary	Function	Function was measured by the Roland-Morris Questionnaire	5 weeks	Yes
Secondary	Postural Control	Postural control was measured by Functional Reach Test and by posturography	5 weeks	Yes