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

Not Applicable

Completed

Brief Summary: 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.

Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Score	3, 6, 12, 18 and 24 months post treatment.	Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Functional Status	3, 6, 12, 18 and 24 months post treatment.	Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.