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

August 10, 2015 updated by: Ricardo de Castro Cintra Sesso, Federal University of São Paulo
The purpose of this study is to determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04023-900
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapeutic intervention
Procedure: physiotherapeutic intervention
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
Other: 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)
Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: eight weeks
eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cep 0087/09 (Other Identifier: Federal University of São Paulo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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