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Treatment of Chronic Low Back and Lower Extremity Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lumbar Interlaminar Epidural

Lumbar Interlaminar Epidural injection

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring lumbar disc herniation, discogenic pain, lumbar interlaminar epidural, injections

Eligibility Criteria

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

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.

Sites / Locations

Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Group I

Group II

Arm Description

Lumbar interlaminar epidural injection with local anesthetic only

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 evaluate and compare the adverse event profile in all patients.

Full Information

NCT ID

NCT00681447

First Posted

March 14, 2008

Last Updated

October 20, 2015

Sponsor

Pain Management Center of Paducah

1. Study Identification

Unique Protocol Identification Number

NCT00681447

Brief Title

Treatment of Chronic Low Back and Lower Extremity Pain

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

December 2014 (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

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Other

Arm Description

Lumbar interlaminar epidural injection with local anesthetic only

Arm Title

Group II

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Lumbar Interlaminar Epidural

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Lumbar Interlaminar Epidural injection

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laxmaiah Manchikanti, MD

Organizational Affiliation

Ambulatory Surgery Center, Paducah

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

25675062

Citation

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.

Results Reference

derived

PubMed Identifier

24452658

Citation

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.

Results Reference

derived

PubMed Identifier

24077199

Citation

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.

Results Reference

derived

PubMed Identifier

22270738

Citation

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.

Results Reference

derived

PubMed Identifier

20648214

Citation

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.

Results Reference

derived

PubMed Identifier

20648203

Citation

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.

Results Reference

derived

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Treatment of Chronic Low Back and Lower Extremity Pain

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