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

1. 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.

2. To evaluate and compare the adverse event profile in all patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• Procedure: Lumbar Interlaminar Epidural
  • Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone
• Procedure: Lumbar Interlaminar Epidural injection
  • Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone

Arms, Groups and Cohorts in this Clinical Trial

• Other: Group I
  • Lumbar interlaminar epidural injection with local anesthetic only
• Other: Group II
  • Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone

Primary Measures

• To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
  • Time Frame: 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.
    Safety Issue?: No

Secondary Measures

• To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
  • Time Frame: 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.
    Safety Issue?: No
• To evaluate and compare the adverse event profile in all patients.
  • Time Frame: 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.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pain Management Center of Paducah

Overall Clinical Trial Officials and Contacts

Laxmaiah Manchikanti, MD Principal Investigator Ambulatory Surgery Center, Paducah  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00681447

Study ID Number: protocol 15

ClinicalTrials.gov Identifier: NCT00681447

Health Authority: United States: Institutional Review Board