Effectiveness of Thoracic Facet Joint Nerve Blocks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT00355706
First received: July 24, 2006
Last updated: September 27, 2013
Last verified: September 2013
Results First Received: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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  
Number of Participants  
[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


  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
No text entered.  


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:

Responsible Party: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00355706     History of Changes
Other Study ID Numbers: protocol 5
Study First Received: July 24, 2006
Results First Received: December 6, 2012
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board