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Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain

Information source: Pain Management Center of Paducah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Back Pain

Intervention: Caudal epidural injection (Drug); Caudal Epidural Injection with generic Celestone (Drug); Caudal Epidural Injection with Celestone (Drug); Caudal Epidural Injection with DepoMedrol (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Pain Management Center of Paducah

Official(s) and/or principal investigator(s):
Laxmaiah Manchikanti, MD, Principal Investigator, Affiliation: Ambulatory Surgery Center

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: To assess adverse events in all four groups.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ambulatory Surgery Center, Paducah, Kentucky 42001, United States
Additional Information

Starting date: January 2007
Last updated: August 14, 2013

Page last updated: August 23, 2015

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