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

Study Overview
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Brief Summary
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Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function. Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group. Compare adverse event profile in both groups

Detailed Description
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Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections. Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.

Official Title
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A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis

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: Over 18 years of age History of chronic, function limiting low back pain of at least 6 months in duration Able to give voluntary, written informed consent Able to understand investigational procedures and willing to return for follow-ups No recent surgical procedures within last 3 months Exclusion Criteria: Large contained or sequestered herniation Cauda Equina symptoms and/or compressive radiculopathy Narcotic use of no greater than 100mg/day Hydrocodone, 60mg Methadone, or 100mg Morphine Uncontrolled major depression or psychiatric disorder Uncontrolled or acute medical illness Chronic sever conditions that could interfere with outcome assessments Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

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>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 | Procedure: Caudal epidural injection<br>* Caudal epidural injection with catheterization<br>|
| Active Comparator: Percutaneous adhesiolysis<br>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 | Procedure: Percutaneous adhesiolysis<br>* Percutaneous adhesiolysis with hypertonic saline neurolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Score | Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable | 3, 6, 12, 18 and 24 months post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status | Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms. | 3, 6, 12, 18 and 24 months post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-lumbar surgery syndrome, percutaneous lumbar epidural adhesiolysis, hypertonic saline neurolysis