Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2008-02-29
2014-12-31
Brief Summary
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2. To evaluate and compare the adverse event profile in all patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group I
Lumbar interlaminar epidural injection with local anesthetic only
Lumbar Interlaminar Epidural
1. Lumbar interlaminar epidural injections under fluoroscopy
2. Epidural tray and needle
3. Drugs:
0.5% Xylocaine and non-particulate Celestone
Lumbar Interlaminar Epidural injection
1. Lumbar interlaminar epidural injections under fluoroscopy
2. Epidural tray and needle
3. Drugs:
0.5% Xylocaine and non-particulate Celestone
Group II
Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone
Lumbar Interlaminar Epidural
1. Lumbar interlaminar epidural injections under fluoroscopy
2. Epidural tray and needle
3. Drugs:
0.5% Xylocaine and non-particulate Celestone
Lumbar Interlaminar Epidural injection
1. Lumbar interlaminar epidural injections under fluoroscopy
2. Epidural tray and needle
3. Drugs:
0.5% Xylocaine and non-particulate Celestone
Interventions
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Lumbar Interlaminar Epidural
1. Lumbar interlaminar epidural injections under fluoroscopy
2. Epidural tray and needle
3. Drugs:
0.5% Xylocaine and non-particulate Celestone
Lumbar Interlaminar Epidural injection
1. Lumbar interlaminar epidural injections under fluoroscopy
2. Epidural tray and needle
3. Drugs:
0.5% Xylocaine and non-particulate Celestone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pain Management Center of Paducah
OTHER
Responsible Party
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Laxmaiah Manchikanti, MD
Medical Director
Principal Investigators
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Laxmaiah Manchikanti, MD
Role: PRINCIPAL_INVESTIGATOR
Ambulatory Surgery Center, Paducah
Locations
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Ambulatory Surgery Center
Paducah, Kentucky, United States
Countries
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References
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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.
Other Identifiers
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protocol 15
Identifier Type: -
Identifier Source: org_study_id
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