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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Caudal epidural injection
Caudal Epidural Injection with generic Celestone
Caudal Epidural Injection with Celestone
Caudal Epidural Injection with DepoMedrol
Sponsored by
Pain Management Center of Paducah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Caudal Epidural injections, lumbar disc herniation, spinal stenosis, discogenic pain, post-lumbar laminectomy syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

local anesthetic

Local anesthetic with generic Celestone

Local anesthetic with Celestone

Local anesthetic with DepoMedrol

Arm Description

Group 1. local anesthetics only

Group 2. local anesthetic with 6mg of non-particulate Celestone

Group 3. local anesthetic with 6 mg of brand nameCelestone

Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol

Outcomes

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

Secondary Outcome Measures

To assess adverse events in all four groups.

Full Information

First Posted
August 30, 2006
Last Updated
August 14, 2013
Sponsor
Pain Management Center of Paducah
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1. Study Identification

Unique Protocol Identification Number
NCT00370799
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pain Management Center of Paducah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Caudal Epidural injections, lumbar disc herniation, spinal stenosis, discogenic pain, post-lumbar laminectomy syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
local anesthetic
Arm Type
Active Comparator
Arm Description
Group 1. local anesthetics only
Arm Title
Local anesthetic with generic Celestone
Arm Type
Active Comparator
Arm Description
Group 2. local anesthetic with 6mg of non-particulate Celestone
Arm Title
Local anesthetic with Celestone
Arm Type
Active Comparator
Arm Description
Group 3. local anesthetic with 6 mg of brand nameCelestone
Arm Title
Local anesthetic with DepoMedrol
Arm Type
Active Comparator
Arm Description
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Intervention Type
Drug
Intervention Name(s)
Caudal epidural injection
Other Intervention Name(s)
Group 1
Intervention Description
group 1: Caudal epidural injection local anesthetics only
Intervention Type
Drug
Intervention Name(s)
Caudal Epidural Injection with generic Celestone
Other Intervention Name(s)
Group 2
Intervention Description
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
Intervention Type
Drug
Intervention Name(s)
Caudal Epidural Injection with Celestone
Other Intervention Name(s)
Group 3
Intervention Description
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
Intervention Type
Drug
Intervention Name(s)
Caudal Epidural Injection with DepoMedrol
Other Intervention Name(s)
Group 4
Intervention Description
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess adverse events in all four groups.
Time Frame
1,3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laxmaiah Manchikanti, MD
Organizational Affiliation
Ambulatory Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Surgery Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22828681
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.
Results Reference
derived
PubMed Identifier
21267039
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.
Results Reference
derived
PubMed Identifier
21102963
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.
Results Reference
derived

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

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