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

Pain Management Center of Paducah120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Low Back Pain

Interventions

Caudal epidural injectionPROCEDURE

Caudal epidural injection with catheterization

Percutaneous adhesiolysisPROCEDURE

Percutaneous adhesiolysis with hypertonic saline neurolysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ambulatory Surgery Center

Paducah, Kentucky, United States

Outcomes

Primary Outcomes

Numeric Pain Rating Score

Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable

Time frame: 3, 6, 12, 18 and 24 months post treatment.

Secondary Outcomes

Functional Status

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.

Time frame: 3, 6, 12, 18 and 24 months post treatment.

Data from ClinicalTrials.gov

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