Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients

Study Overview
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Brief Summary
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To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome. To 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 lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections. This is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the United States. The study involves 240 patients studied in 4 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding. 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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Evaluation of the Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients: A Prospective, Randomized, Double-Blind, Equivalence, Controlled Trial of Percutaneous Lumbar Adhesiolysis

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Adhesiolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: History of lumbar surgery of at least 6 months duration in the past Patients over the age of 18 years Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration (post-surgery) Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements. Exclusion criteria: Facet joints, uncontrollable as sole pain generators Unstable or heavy opioid use (400 mg of morphine equivalents daily) 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 anesthetic, steroids, or hypertonic sodium chloride solution.

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: Celestone<br>Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone | Procedure: Adhesiolysis<br>* Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone<br>* Other names: Adhesiolysis in post-surgery;|
| Active Comparator: sodium chloride solution<br>Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone | Procedure: Adhesiolysis<br>* Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone<br>* Other names: Adhesiolysis in post-surgery;|
| Active Comparator: sodium choride solution<br>Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone; | Procedure: Adhesiolysis<br>* Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone<br>* Other names: Adhesiolysis in post-surgery;|
| Active Comparator: Double substitutes<br>Group IV will receive adhesiolysis, local anesthetic, and 0.9% sodium chloride solution to substitute for the 10% hypertonic sodium chloride, and 0.9% sodium chloride solution to substitute for non-particulate Celestone | Procedure: Adhesiolysis<br>* Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone<br>* Other names: Adhesiolysis in post-surgery;|

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. | Record side effects and any 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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Chronic low back pain, Post lumbar laminectomy syndrome, Lower extremity pain, Local anesthetic, Steroid, Percutaneous lumbar adhesiolysis