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A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053273
First Posted: January 21, 2010
Last Update Posted: April 25, 2017
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
January 19, 2010
January 21, 2010
April 25, 2017
February 2010
January 2012   (Final data collection date for primary outcome measure)
Numeric rating scale (NRS), Oswestry Disability Index (ODI) [ Time Frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. ]
duration of significant pain relief, opioid intake, and return to work
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work [ Time Frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. ]
Complete list of historical versions of study NCT01053273 on ClinicalTrials.gov Archive Site
Adverse event profile of side effects and complications. [ Time Frame: Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected. ]
List and look at all side effects and complications
Adverse event profile of side effects and complications. [ Time Frame: Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected. ]
Not Provided
Not Provided
 
A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial

The purpose of this study is to:

  • evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.
  • evaluate and compare the adverse event profile in all groups.

Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.

This is a single-center study performed in an interventional pain management referral center in the United States.

The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.

Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Low Back Pain
  • Procedure: Caudal Epidural Injection
    Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
  • Procedure: percutaneous adhesiolysis
    Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.
  • Active Comparator: Caudal epidural Injection
    Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
    Intervention: Procedure: Caudal Epidural Injection
  • Active Comparator: Percutaneous Adhesiolysis
    Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
    Intervention: Procedure: percutaneous adhesiolysis
Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar-Apr;13(2):E91-E110.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 27, 2014
January 2012   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with history of lumbar surgery of at least 6 months duration in the past
  • Patients over the 18 years of age
  • Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration
  • Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements

Exclusion criteria:

  • Post surgery, central spinal stenosis, and facet joints as sole pain generators
  • Unstable or heavy opioid use
  • Uncontrolled psychiatric disorders
  • Uncontrolled medical illness
  • Any conditions that could interfere with the interpretation of the outcome assessments
  • Pregnant or lactating women
  • Patients with a history or potential for adverse reaction(s) to local anesthetics or steroid.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01053273
Protocol 27
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Pain Management Center of Paducah
Not Provided
Principal Investigator: Laxmaiah Manchikanti Ambulatory Surgery Center, Paducah
Pain Management Center of Paducah
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP