Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
This study has been completed.
Sponsor:
Centro Universitari Fieo
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
| Tracking Information | |||||
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| First Received Date ICMJE | April 4, 2011 | ||||
| Last Updated Date | April 26, 2011 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Perceived pain [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ] Pain was measured by an Analogic Visual Scale |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01342432 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients | ||||
| Official Title ICMJE | Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 35 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 69 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01342432 | ||||
| Other Study ID Numbers ICMJE | 2008/069241 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Thais Weber Alencar Bojadsen, PhD, Centro Universitário Fieo | ||||
| Study Sponsor ICMJE | Centro Universitari Fieo | ||||
| Collaborators ICMJE | University of Sao Paulo | ||||
| Investigators ICMJE |
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| Information Provided By | Centro Universitari Fieo | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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