Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2006

Last Updated Date

March 9, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate for difference between the patients in various groups in the physical function and pain at 3, 6, 12, 18 and 24 months post treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00370994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess adverse events in both groups.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

Official Title ^ICMJE

Treatment of Chronic Low Back and Lower Extremity Pain Secondary to Spinal Stenosis for Post-Lumbar Surgery Syndrome: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis

Brief Summary

To demonstrate clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function.

To assess improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.

To evaluate and compare adverse event profile in both groups

Detailed Description

Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections.

Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Low Back Pain

Intervention ^ICMJE

Procedure: Percutaneous adhesiolysis with hypertonic saline neurolysis
Device: RK needle and Racz catheter system
Drug: local anesthetic, steroid, 10% sodium chloride solution

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

July 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Over 18 years of age
History of chronic, function limiting low back pain of at least 6 months in duration
Able to give voluntary, written informed consent
Able to understand investigational procedures and willing to return for follow-ups
No recent surgical procedures within last 3 months

Exclusion Criteria:

Large contained or sequestered herniation
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 psychiatric disorder
Uncontrolled or acute medical illness
Chronic sever 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00370994

Responsible Party

Study ID Numbers ^ICMJE

protocol 11

Study Sponsor ^ICMJE

Pain Management Center of Paducah

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center

Information Provided By

Pain Management Center of Paducah

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP