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

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ClinicalTrials.gov Identifier: NCT01053273
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Caudal Epidural Injection Procedure: percutaneous adhesiolysis Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
Actual Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 27, 2014

Arm Intervention/treatment
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
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

Active Comparator: Percutaneous Adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
Procedure: percutaneous adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053273


Locations
United States, Kentucky
Pain Management Center of Paducah
Paducah, Kentucky, United States, 42001
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti Ambulatory Surgery Center, Paducah

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT01053273     History of Changes
Other Study ID Numbers: Protocol 27
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laxmaiah Manchikanti, MD, Pain Management Center of Paducah:
Low back pain
Post lumbar laminectomy syndrome
Lumbar spinal stenosis
Local anesthetic steroid
Lumbar transforaminal epidural injection
Percutaneous epidural adhesiolysis
Caudal epidural injection

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharmaceutical Solutions
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents