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

Pain Management Center of Paducah

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Percutaneous adhesiolysis; Procedure: Caudal epidural injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00370994

protocol 11

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Caudal epidural injection

Active Comparator group

Description:

Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution

Treatment:

Procedure: Caudal epidural injection

Percutaneous adhesiolysis

Active Comparator group

Description:

Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution

Treatment:

Procedure: Percutaneous adhesiolysis