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

Phase 3

Withdrawn

• Conditions: Chronic Low Back Pain
• Interventions: Procedure: control; Procedure: physiotherapeutic intervention

• Registration Number: NCT01095783
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2013-09
• Study Completion: 2014-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	The control group receive transcutaneous electrical nerve stimulation (TENS) for 20 min at 50-100 Hz frequencies for the same time frame (Anesth Analg 2004;98:1552-6)
Physiotherapeutic intervention	physiotherapeutic intervention	-

Primary Outcome Measures

Name	Time	Method
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.	eight weeks

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil