Effectiveness of Cervical 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:
NCT00332722
First received: May 31, 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: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Neck Pain
Intervention: Procedure: Cervical facet joint nerve blocks

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Consecutive new patients presenting to interventional pain management practice with neck pain without suspected disc herniation or radiculitis.

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 1 Without Steroids Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
Group 2 With Steroids Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)

Participant Flow:   Overall Study
    Group 1 Without Steroids     Group 2 With Steroids  
STARTED     60     60  
COMPLETED     60     60  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 1- Without Steroid Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
Group 2 - With Steroid Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Total Total of all reporting groups

Baseline Measures
    Group 1- Without Steroid     Group 2 - With Steroid     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     60     60     120  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 13.2     43  ± 14.1     44  ± 13.7  
Gender  
[units: participants]
     
Female     41     48     89  
Male     19     12     31  
duration of pain  
[units: months]
Mean ± Standard Deviation
  120  ± 122     87  ± 104     103  ± 174  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Numeric Rating Scale (NRS)   [ Time Frame: over 2 years ]

2.  Secondary:   Neck Disability Index (NDI)   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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
The study limitations include the lack of a placebo group.  


Results Point of Contact:  
Name/Title: Dr. Laxmaiah Manchikanti, MD
Organization: Pain Management Center of Paducah
phone: 2705548373 ext 101
e-mail: drlm@thepainmd.com


Publications of Results:

Responsible Party: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00332722     History of Changes
Other Study ID Numbers: Protocol4
Study First Received: May 31, 2006
Results First Received: December 6, 2012
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board