Treatment of Chronic Low Back and Lower Extremity Pain

Study Overview
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Brief Summary
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To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function. To evaluate and compare the adverse event profile in all patients.

Official Title
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A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Lumbar Interlaminar Epidural
* Procedure: Lumbar Interlaminar Epidural injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of at least 18 years of age Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups Subjects have not had recent surgical procedures within the last 3 months. Exclusion Criteria: Cauda Equina symptoms and/or compressive radiculopathy Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent Uncontrolled major depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers Previous surgery.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group I<br>Lumbar interlaminar epidural injection with local anesthetic only | Procedure: Lumbar Interlaminar Epidural<br>* Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone<br>Procedure: Lumbar Interlaminar Epidural injection<br>* Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone<br>|
| Other: Group II<br>Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone | Procedure: Lumbar Interlaminar Epidural<br>* Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone<br>Procedure: Lumbar Interlaminar Epidural injection<br>* Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. |  | Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. |  | Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. | 
| To evaluate and compare the adverse event profile in all patients. |  | Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar disc herniation, discogenic pain, lumbar interlaminar epidural, injections