Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Federal University of São Paulo.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01095783
First received: March 29, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | March 29, 2010 | ||||
| Last Updated Date | March 29, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improvement in functional status of the lumbar spine as measured by the Roland Morris Disability questionnaire, consisting of 24 items wich are reported by the patient. Additionally, the lumbar pain will be assessed by a visual analogue scale. [ Time Frame: eight weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients |
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| Detailed Description | Low back pain is a significant morbidity in chronic hemodialysis patients affecting about 1/3 of them. Among the physiotherapeutic interventions, the McKenzie Method (Spine 1983;8:141-4), has shown to be an effective approach to manage patients with low back pain. More specifically, it consists on standardized repetitive flexion and extension exercises of the lumbar spine. Thus far, there has been no randomized intervention testing the effectiveness of physiotherapeutic interventions in chronic renal failure patients on hemodialysis. In this study we selected four of their main proposed exercises (flexion in standing, extension in standing, flexion in lying, and extension in lying position) to apply three times a week for eight weeks. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Cristofolini T, Draibe S, Sesso R. Evaluation of factors associated with chronic low back pain in hemodialysis patients. Nephron Clin Pract. 2008;108(4):c249-55. Epub 2008 Apr 9. | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | July 2011 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01095783 | ||||
| Other Study ID Numbers ICMJE | CEP 0087/09, cep 0087/09 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Ricardo Sesso, Federal University of São Paulo | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | February 2010 | ||||
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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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