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A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

This study has been completed.
Sponsor:
Collaborators:
Walter Reed Army Medical Center
National Naval Medical Center
Womack Army Medical Center
Landstuhl Regional Medical Center
Massachusetts General Hospital
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00733096
First received: August 11, 2008
Last updated: October 5, 2012
Last verified: September 2010
History of Changes
Results First Received: August 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lumbosacral Radiculopathy
Interventions: Drug: etanercept
Drug: methylprednisolone
Drug: normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
84 patients were enrolled between 2008 and 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
80 patients were excluded before assignment

Reporting Groups
  Description
Steroid Two epidural steroid injections
Etanercept Two epidural etanercept injections
Saline Two epidural saline injections

Participant Flow:   Overall Study
    Steroid     Etanercept     Saline  
STARTED     28     26     30  
COMPLETED     28     26     30  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Steroid Two epidural steroid injections
Etanercept Two epidural etanercept injections
Saline Two epidural saline injections
Total Total of all reporting groups

Baseline Measures
    Steroid     Etanercept     Saline     Total  
Number of Participants  
[units: participants]
 		  28     26     30     84  
Age  
[units: years]
Mean ± Standard Deviation 		  41.4  ± 12.7     43.2  ± 8.9     42.3  ± 10.7     42.29  ± 10.80  
Gender  
[units: participants]
 		       
Female     6     8     11     25  
Male     22     18     19     59  
Region of Enrollment  
[units: participants]
 		       
United States     28     26     30     84  



  Outcome Measures
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1.  Primary:   Numerical Rating Leg Pain Score   [ Time Frame: 1 month ]
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2.  Secondary:   Oswestry Disability Score   [ Time Frame: 1 month ]
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3.  Secondary:   Global Perceived Effect   [ Time Frame: 1 month ]
  Show Outcome Measure 3

4.  Secondary:   Medication Reduction   [ Time Frame: 1 month ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Subjects who failed to obtain benefit were unblinded after 1-month, which limits conclusions regarding long-term efficacy.  


Results Point of Contact:  
Name/Title: Steven P. Cohen
Organization: Johns Hopkins School of Medicine
phone: 410-955-1822
e-mail: scohen40@jhmi.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: Steven P. cohen, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00733096     History of Changes
Other Study ID Numbers: 08-6891
Study First Received: August 11, 2008
Results First Received: August 24, 2012
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board