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

Chronic Low Back Pain Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01095783
• Other study ID #: CEP 0087/09
• Secondary ID: cep 0087/09
• Status: Withdrawn
• Phase: Phase 3
• First received: March 29, 2010
• Last updated: August 10, 2015
• Start date: March 2009
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Research Council
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Kidney Failure, Chronic
• Low Back Pain

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
• 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)

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No