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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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Overall Participants Analyzed 
[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 ]

2.  Secondary:   Oswestry Disability Score   [ Time Frame: 1 month ]

3.  Secondary:   Global Perceived Effect   [ Time Frame: 1 month ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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 by ClinicalTrials.gov Identifier (NCT Number):

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