Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, 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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
  Hide 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.


  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.


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