Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain - Full Text View

Sponsor:	Pain Management Center of Paducah
Information provided by:	Pain Management Center of Paducah
ClinicalTrials.gov Identifier:	NCT00370799

Purpose

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

Condition	Intervention	Phase
Low Back Pain	Drug: Caudal epidural injection Drug: Caudal Epidural Injection with generic Celestone Drug: Caudal Epidural Injection with Celestone Drug: Caudal Epidural Injection with DepoMedrol	Phase 0

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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Hernia Spinal Stenosis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Bentelan Betamethasone Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate Betamethasone dipropionate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:

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 [ Time Frame: 1,3,6,12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess adverse events in all four groups. [ Time Frame: 1,3,6,12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	January 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: local anesthetic Group 1. local anesthetics only	Drug: Caudal epidural injection group 1: Caudal epidural injection local anesthetics only Other Name: Group 1
Active Comparator: Local anesthetic with generic Celestone Group 2. local anesthetic with 6mg of non-particulate Celestone	Drug: Caudal Epidural Injection with generic Celestone Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone Other Name: Group 2
Active Comparator: Local anesthetic with Celestone Group 3. local anesthetic with 6 mg of brand nameCelestone	Drug: Caudal Epidural Injection with Celestone Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone Other Name: Group 3
Active Comparator: Local anesthetic with DepoMedrol Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol	Drug: Caudal Epidural Injection with DepoMedrol Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol Other Name: Group 4

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370799

Locations

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

Sponsors and Collaborators

Pain Management Center of Paducah

Investigators

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center

More Information

No publications provided by Pain Management Center of Paducah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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;14(1):25-36.

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 Dec;13(6):509-21.

Responsible Party:	Laxmaiah Manchikanti, MD/Medical Director, Pain Management Center of Paducah and Ambulatory Surgery Center
ClinicalTrials.gov Identifier:	NCT00370799 History of Changes
Other Study ID Numbers:	protocol 10
Study First Received:	August 30, 2006
Last Updated:	February 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:

Caudal Epidural injections
lumbar disc herniation
spinal stenosis
discogenic pain
post-lumbar laminectomy syndrome

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Spinal Stenosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics, Local
Anesthetics
Betamethasone-17,21-dipropionate
Methylprednisolone acetate
Prednisolone acetate

Betamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Betamethasone sodium phosphate
Prednisolone phosphate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 09, 2012