NCT01342432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
Last Updated

April 27, 2011

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

April 4, 2011

Last Update Submit

April 26, 2011

Conditions

Low Back Pain

Keywords

low back painbalance reeducationpainfunction

Outcome Measures

Primary Outcomes (1)

  • Perceived pain

    Pain was measured by an Analogic Visual Scale

    5 weeks

Secondary Outcomes (2)

  • Function

    5 weeks

  • Postural Control

    5 weeks

Study Arms (2)

Balance reeducation plus exercise

EXPERIMENTAL

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

General exercise only

OTHER

general exercise for stretch and strength of paraspinal and abdominal muscles

Other: General exercise only

Interventions

General exercise onlyOTHER

exercises for stretch and strength of paraspinal and abdominal muscles

Also known as: control group
General exercise only
Balance reeducation plus general exerciseOTHER

patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles

Also known as: balance group, intervention group
Balance reeducation plus exercise

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must have low back pain longer than three months and age between 40 and 69 years old

You may not qualify if:

  • balance or neuromuscular disorders, spine surgery, diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário Fieo

Osasco, São Paulo, 06020-190, Brazil

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Thais Bojadsen, PhD

    Centro Universitario Fieo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 27, 2011

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

April 27, 2011

Record last verified: 2009-12

Locations

BR(1)