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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Procedure: physiotherapeutic intervention
* Procedure: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapeutic intervention<br> | Procedure: physiotherapeutic intervention<br>* Twenty repetitive exercises (30 seconds per exercise) consisting of: flexion in standing, extension in standing, flexion in lying, and extension in lying position applied three times a week for eight weeks<br>|
| Other: control<br>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) | Procedure: control<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, physiotherapy, hemodialysis, end-stage renal disease