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

Primary Purpose

Chronic Low Back Pain

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
physiotherapeutic intervention
control
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, physiotherapy, hemodialysis, end-stage renal disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Physiotherapeutic intervention

control

Arm Description

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)

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2010
Last Updated
August 10, 2015
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01095783
Brief Title
Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
My main collaborator got sick and cannot continue the project. The study ended.
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, physiotherapy, hemodialysis, end-stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapeutic intervention
Arm Type
Experimental
Arm Title
control
Arm Type
Other
Arm Description
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
Intervention Name(s)
physiotherapeutic intervention
Intervention Description
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
Intervention Name(s)
control
Intervention Description
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)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04023-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18401192
Citation
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.
Results Reference
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Learn more about this trial

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

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