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Effectiveness of Thoracic Facet Joint Nerve Blocks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355706
First Posted: July 25, 2006
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Results First Submitted: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Intervention: Procedure: Thoracic facet joint nerve blocks

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group I - Without Steroids Group I - Thoracic medial branch blocks with local anesthetics
Group II - With Steroids Group II - Thoracic medial branch blocks with bupivacaine and steroid

Participant Flow:   Overall Study
    Group I - Without Steroids   Group II - With Steroids
STARTED   50   50 
COMPLETED   50   50 
NOT COMPLETED   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.
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Reporting Groups
  Description
Group I - With Local Anesthetics Group I - Thoracic medial branch blocks with local anesthetics
Group II - With Bupivacaine and Steroid Group II - Thoracic medial branch blocks with bupivacaine and steroid
Total Total of all reporting groups

Baseline Measures
   Group I - With Local Anesthetics   Group II - With Bupivacaine and Steroid   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   47   50   97 
>=65 years   3   0   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.7  (11.7)   42.8  (12.3)   43.8  (12.0) 
Gender 
[Units: Participants]
     
Female   31   32   63 
Male   19   18   37 


  Outcome Measures
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1.  Primary:   Numeric Rating Scale   [ Time Frame: 2 years ]

2.  Primary:   Oswestry Disability Index   [ Time Frame: 24 months ]

3.  Other Pre-specified:   Opioid Intake   [ Time Frame: 24 months ]


  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
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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.


Results Point of Contact:  
Name/Title: Laxmaiah Manchikanti, MD
Organization: Pain Management Center of Paducah
phone: 2705548373 ext 100
e-mail: drm@asipp.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00355706     History of Changes
Other Study ID Numbers: protocol 5
First Submitted: July 24, 2006
First Posted: July 25, 2006
Results First Submitted: December 6, 2012
Results First Posted: November 26, 2013
Last Update Posted: November 26, 2013