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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Caudal Epidural Injection
* Procedure: percutaneous adhesiolysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal epidural Injection<br>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<br>* Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution<br>|
| Active Comparator: Percutaneous Adhesiolysis<br>Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone | Procedure: percutaneous adhesiolysis<br>* Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS), Oswestry Disability Index (ODI) | duration of significant pain relief, opioid intake, and return to work | Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile of side effects and complications. | List and look at all side effects and complications | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Post lumbar laminectomy syndrome, Lumbar spinal stenosis, Local anesthetic steroid, Lumbar transforaminal epidural injection, Percutaneous epidural adhesiolysis, Caudal epidural injection