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CompletedNCT00370799Updated Aug 16, 2013

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

An Early Phase 1 interventional study of Caudal epidural injection and Caudal Epidural Injection with generic Celestone in Low Back Pain, sponsored by Pain Management Center of Paducah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-16.

Sponsored by Pain Management Center of Paducah · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

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Conditions studied

  • Low Back Pain

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Keywords

  • Caudal Epidural injections
  • lumbar disc herniation
  • spinal stenosis
  • discogenic pain
  • post-lumbar laminectomy syndrome
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 240 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Pain Management Center of Paducah is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    local anesthetic

    Group 1. local anesthetics only

    Drug: Caudal epidural injection

  • Active comparator
    Local anesthetic with generic Celestone

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

    Drug: Caudal Epidural Injection with generic Celestone

  • Active comparator
    Local anesthetic with Celestone

    Group 3. local anesthetic with 6 mg of brand nameCelestone

    Drug: Caudal Epidural Injection with Celestone

  • Active comparator
    Local anesthetic with DepoMedrol

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

    Drug: Caudal Epidural Injection with DepoMedrol

Interventions

  • DrugCaudal epidural injection

    group 1: Caudal epidural injection local anesthetics only

    Also known as: Group 1

  • DrugCaudal Epidural Injection with generic Celestone

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

    Also known as: Group 2

  • DrugCaudal Epidural Injection with Celestone

    Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone

    Also known as: Group 3

  • DrugCaudal Epidural Injection with DepoMedrol

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

    Also known as: Group 4

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. To assess adverse events in all four groups.

    Time frame: 1,3,6,12 months

07

Study locations

1 site
  • Ambulatory Surgery Center
    Paducah, Kentucky 42001, United States
08

References and documents

Publications

  • 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. PubMed 22828681 ↗
  • 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. PubMed 21267039 ↗
  • 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. PubMed 21102963 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00370799
Lead sponsor
Pain Management Center of Paducah
Responsible party
Laxmaiah Manchikanti, MD (Medical Director, Pain Management Center of Paducah) — Principal investigator
First posted
Sep 1, 2006
Start date
Jan 2007
Primary completion
Dec 2009
Completion
Mar 2010
Last update
Aug 16, 2013

Study contacts

Laxmaiah Manchikanti, MD
principal investigator · Ambulatory Surgery Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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