Treatment of Chronic Low Back and Lower Extremity Pain

• ClinicalTrials.gov Identifier: NCT00681447
• Recruitment Status: Completed
• First Posted: May 21, 2008
• Last Update Posted: October 21, 2015
• Sponsor: Pain Management Center of Paducah
• Information provided by (Responsible Party): Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Procedure: Lumbar Interlaminar Epidural; Procedure: Lumbar Interlaminar Epidural injection	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain
• Study Start Date: February 2008
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Group I; Lumbar interlaminar epidural injection with local anesthetic only	Procedure: Lumbar Interlaminar Epidural; Lumbar interlaminar epidural injections under fluoroscopy; Epidural tray and needle; Drugs: 0.5% Xylocaine and non-particulate Celestone; Procedure: Lumbar Interlaminar Epidural injection; Lumbar interlaminar epidural injections under fluoroscopy; Epidural tray and needle; Drugs: 0.5% Xylocaine and non-particulate Celestone
Group II; Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone	Procedure: Lumbar Interlaminar Epidural; Lumbar interlaminar epidural injections under fluoroscopy; Epidural tray and needle; Drugs: 0.5% Xylocaine and non-particulate Celestone; Procedure: Lumbar Interlaminar Epidural injection; Lumbar interlaminar epidural injections under fluoroscopy; Epidural tray and needle; Drugs: 0.5% Xylocaine and non-particulate Celestone

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

• 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.

Contacts and Locations

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, Paducah

More Information

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

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.

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.

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.

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.

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.

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.

• Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
• ClinicalTrials.gov Identifier: NCT00681447
• Other Study ID Numbers: protocol 15
• First Posted: May 21, 2008
• Last Update Posted: October 21, 2015
• Last Verified: October 2015

Keywords provided by Laxmaiah Manchikanti, MD, Pain Management Center of Paducah:

lumbar disc herniation; discogenic pain; lumbar interlaminar epidural; injections

Additional relevant MeSH terms:

Low Back Pain; Back Pain; Pain; Neurologic Manifestations