CClinicalTrials.gg
Sign In
CompletedNCT00681447Updated Oct 21, 2015

Treatment of Chronic Low Back and Lower Extremity Pain

An interventional study of Lumbar Interlaminar Epidural and Lumbar Interlaminar Epidural injection 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 2015-10-21.

Sponsored by Pain Management Center of Paducah · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

  1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
  2. To evaluate and compare the adverse event profile in all patients.
02

Conditions studied

  • Low Back Pain

Browse trials for

Keywords

  • lumbar disc herniation
  • discogenic pain
  • lumbar interlaminar epidural
  • injections
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 120 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

  • Subjects of at least 18 years of age
  • Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation
  • Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
  • Subjects have not had recent surgical procedures within the last 3 months.

Exclusion criteria

Exclusion Criteria:

  • Cauda Equina symptoms and/or compressive radiculopathy
  • Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
  • Uncontrolled major depression or uncontrolled psychiatric disorders
  • Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
  • Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
  • 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, due to the overlap of pain complaints
  • Inability to achieve appropriate 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
  • Previous surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Other
    Group I

    Lumbar interlaminar epidural injection with local anesthetic only

    Procedure: Lumbar Interlaminar Epidural · Procedure: Lumbar Interlaminar Epidural injection

  • Other
    Group II

    Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone

    Procedure: Lumbar Interlaminar Epidural · Procedure: Lumbar Interlaminar Epidural injection

Interventions

  • ProcedureLumbar Interlaminar Epidural

    1. Lumbar interlaminar epidural injections under fluoroscopy 2. Epidural tray and needle 3. Drugs: 0.5% Xylocaine and non-particulate Celestone

  • ProcedureLumbar Interlaminar Epidural injection

    1. Lumbar interlaminar epidural injections under fluoroscopy 2. Epidural tray and needle 3. Drugs: 0.5% Xylocaine and non-particulate Celestone

06

What researchers measure

Primary outcomes

  1. To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.

    Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.

Secondary outcomes

  1. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

    Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.

  2. To evaluate and compare the adverse event profile in all patients.

    Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.

07

Study locations

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

References and documents

Publications

  • Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. A randomized, double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis: 2-year follow-up. Pain Physician. 2015 Jan-Feb;18(1):79-92. PubMed 25675062 ↗
  • Manchikanti L, Singh V, Cash KA, Pampati V, Falco FJ. A randomized, double-blind, active-control trial of the effectiveness of lumbar interlaminar epidural injections in disc herniation. Pain Physician. 2014 Jan-Feb;17(1):E61-74. PubMed 24452658 ↗
  • Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: results of 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):E491-504. PubMed 24077199 ↗
  • Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):51-63. PubMed 22270738 ↗
  • Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. Preliminary results of a randomized, double-blind, controlled trial of fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar discogenic pain without disc herniation or radiculitis. Pain Physician. 2010 Jul-Aug;13(4):E279-92. PubMed 20648214 ↗
  • Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):343-55. PubMed 20648203 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00681447
Lead sponsor
Pain Management Center of Paducah
Responsible party
Laxmaiah Manchikanti, MD (Medical Director, Pain Management Center of Paducah) — Principal investigator
First posted
May 21, 2008
Start date
Feb 2008
Primary completion
Feb 2010
Completion
Dec 2014
Last update
Oct 21, 2015

Study contacts

Laxmaiah Manchikanti, MD
principal investigator · Ambulatory Surgery Center, Paducah

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Low Back Pain→

Other studies from this sponsor

Pain Management Center of Paducah

Start the discussion