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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01095783
First received: March 29, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

The purpose of this study is to determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients


Condition Intervention Phase
Chronic Low Back Pain
Procedure: physiotherapeutic intervention
Procedure: control
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095783

Contacts
Contact: Ricardo Sesso, MD 55 1159041699 rsesso@unifesp.br

Locations
Brazil
Federal University of São Paulo Recruiting
São Paulo, Brazil, 04023-900
Contact: Ricardo Sesso, MD    55 11 59041699    rsesso@unifesp.br   
Sub-Investigator: Tatiana Cristofolini, MSc         
Principal Investigator: Ricardo Sesso, MD         
Sponsors and Collaborators
Federal University of São Paulo
  More Information

Publications:
Responsible Party: Ricardo Sesso, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01095783     History of Changes
Other Study ID Numbers: CEP 0087/09, cep 0087/09
Study First Received: March 29, 2010
Last Updated: March 29, 2010
Health Authority: Brazil: National Research Council

Keywords provided by Federal University of São Paulo:
low back pain
physiotherapy
hemodialysis
end-stage renal disease

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Kidney Failure, Chronic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014