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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370994
First Posted: September 1, 2006
Last Update Posted: November 23, 2015
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: March 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Procedure: Caudal epidural injection
Procedure: Percutaneous adhesiolysis

  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
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
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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
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 
Overall Participants Analyzed 
[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
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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
The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group.


  More Information
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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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00370994     History of Changes
Other Study ID Numbers: protocol 11
First Submitted: August 30, 2006
First Posted: September 1, 2006
Results First Submitted: March 21, 2012
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015