Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT00370994
First received: August 30, 2006
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: March 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Procedure: Caudal epidural injection
Procedure: Percutaneous adhesiolysis

  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
An interventional pain management practice, a specialty referral center, a private practice setting in the United States

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
Caudal Epidural Injection Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
Pecutaneous Adhesiolysis Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution

Participant Flow:   Overall Study
    Caudal Epidural Injection     Pecutaneous Adhesiolysis  
STARTED     60 [1]   60  
COMPLETED     60     60  
NOT COMPLETED     0     0  
[1] Sample size was 200, due to the difficulties of recruiting we changed to 120



  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
Caudal Epidural Injection Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
Pecutaneous Adhesiolysis Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
Total Total of all reporting groups

Baseline Measures
    Caudal Epidural Injection     Pecutaneous Adhesiolysis     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     44     48     92  
>=65 years     16     12     28  
Age  
[units: years]
Mean (Standard Deviation)
  52  (13.9)     52  (12.5)     52  (13.2)  
Gender  
[units: participants]
     
Female     35     35     70  
Male     25     25     50  
Region of Enrollment  
[units: participants]
     
United States     60     60     120  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Numeric Pain Rating Score   [ Time Frame: 3, 6, 12, 18 and 24 months post treatment. ]

2.  Secondary:   Functional Status   [ Time Frame: 3, 6, 12, 18 and 24 months post treatment. ]


  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 results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Laxmaiah Manchikanti
Organization: Pain Management Center of Paducah
phone: 270-554-8373 ext 101
e-mail: drlm@thepainmd.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00370994     History of Changes
Other Study ID Numbers: protocol 11
Study First Received: August 30, 2006
Results First Received: March 21, 2012
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board