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Clinical Trials/NCT01095783
NCT01095783
Withdrawn
Phase 3

Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis

Federal University of São Paulo1 site in 1 countryMarch 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Federal University of São Paulo
Locations
1
Primary Endpoint
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.
Status
Withdrawn
Last Updated
10 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Ricardo de Castro Cintra Sesso

Associate Professor

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of chronic low back pain
  • Chronic renal failure
  • Hemodialysis therapy for more than 3 months

Exclusion Criteria

  • Fractures of the spine
  • Psychiatric diseases
  • Alcohol of other drugs use
  • Planned living donor transplantation
  • Clinically unstable patients
  • Chronic neurologic diseases

Outcomes

Primary Outcomes

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

Study Sites (1)

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