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

Sponsor:	Pain Management Center of Paducah
Information provided by:	Pain Management Center of Paducah
ClinicalTrials.gov Identifier:	NCT00370994

Purpose

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Back Pain Spinal Stenosis Surgery

Drug Information available for: Sodium chloride

U.S. FDA Resources

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

To assess adverse events in both groups.

Estimated Enrollment:	120
Study Start Date:	January 2006
Study Completion Date:	July 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370994

Locations

United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42003

Sponsors and Collaborators

Pain Management Center of Paducah

Investigators

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center

More Information

No publications provided

Study ID Numbers:	protocol 11
Study First Received:	August 30, 2006
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00370994 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:

spinal stenosis
post-lumbar surgery syndrome
percutaneous lumbar epidural adhesiolysis
hypertonic saline neurolysis

Additional relevant MeSH terms:

Spinal Diseases
Physiological Effects of Drugs
Nervous System Diseases
Low Back Pain
Anesthetics
Central Nervous System Depressants
Pain
Back Pain
Bone Diseases
Pharmacologic Actions

Spinal Stenosis
Anesthetics, Local
Signs and Symptoms
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009