Study Stopped
My main collaborator got sick and cannot continue the project. The study ended.
Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis
2 other identifiers
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2009
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 29, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 11, 2015
August 1, 2015
4.5 years
March 29, 2010
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Physiotherapeutic intervention
EXPERIMENTALcontrol
OTHERThe 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
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
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)
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic low back pain
- Chronic renal failure
- Hemodialysis therapy for more than 3 months
You may not qualify if:
- Fractures of the spine
- Psychiatric diseases
- Alcohol of other drugs use
- Planned living donor transplantation
- Clinically unstable patients
- Chronic neurologic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of São Paulo
São Paulo, São Paulo, 04023-900, Brazil
Related 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.
PMID: 18401192BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 29, 2010
First Posted
March 30, 2010
Study Start
March 1, 2009
Primary Completion
September 1, 2013
Study Completion
September 1, 2014
Last Updated
August 11, 2015
Record last verified: 2015-08