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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370799
First Posted: September 1, 2006
Last Update Posted: August 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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

Further study details as provided by Laxmaiah Manchikanti, MD, 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 ]

Secondary Outcome Measures:
  • To assess adverse events in all four groups. [ Time Frame: 1,3,6,12 months ]

Enrollment: 240
Study Start Date: January 2007
Study Completion Date: March 2010
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00370799     History of Changes
Other Study ID Numbers: protocol 10
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: August 16, 2013
Last Verified: August 2013

Keywords provided by Laxmaiah Manchikanti, MD, 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
Anesthetics, Local
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Methylprednisolone acetate
Prednisolone acetate
Betamethasone
Betamethasone Valerate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Betamethasone sodium phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids