Clinical trial NCT00370799: Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
Official title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Low Back Pain
Keywords: Caudal Epidural injections
lumbar disc herniation
spinal stenosis
discogenic pain
post-lumbar laminectomy syndrome
Lead sponsor: Pain Management Center of Paducah
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids.

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

To assess improvements among patients and compare steroid groups with each other and local anesthetic group.

To evaluate and compare the adverse event profile in all patients

Detailed description: Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises.

A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups.

* Group 1. local anesthetics only
* Group 2. local anesthetic with 6mg of non-particulate Celestone
* Group 3. local anesthetic with 6 mg of brand name Celestone
* Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol

All patients will be unblinded in 12 months.

Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* History of chronic, function-limiting low back pain of at least 6 months duration
* Able to give voluntary, written informed consent to participate,
* Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
* No recent surgical procedures within last three months

Exclusion Criteria:

* 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 uncontrolled psychiatric disorder
* Uncontrolled or acute medical illnesses
* Chronic severe 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
* Patients with multiple complaints involving concomitant hip osteoarthritis
* Inability to achieve proper 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

Primary outcomes:
measure: To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment
timeFrame: 1,3,6,12 months
Secondary outcomes:
measure: To assess adverse events in all four groups.
timeFrame: 1,3,6,12 months
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Ambulatory Surgery Center
state: Kentucky
Study officials:
affiliation: Ambulatory Surgery Center
name: Laxmaiah Manchikanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. 2012 Jul-Aug;15(4):273-86.
citation: Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis. Pain Physician. 2011 Jan-Feb;14(1):25-36.
citation: Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.