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

NCT ID: NCT01095783

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapeutic intervention

Group Type: EXPERIMENTAL

physiotherapeutic intervention

Intervention Type: PROCEDURE

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

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)

Group Type: OTHER

control

Intervention Type: PROCEDURE

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)

Interventions

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

Intervention Type: 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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ricardo de Castro Cintra Sesso

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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. doi: 10.1159/000124328. Epub 2008 Apr 9.

Reference Type: BACKGROUND

PMID: 18401192 (View on PubMed)

Other Identifiers

cep 0087/09

Identifier Type: OTHER

Identifier Source: secondary_id

CEP 0087/09

Identifier Type: -

Identifier Source: org_study_id