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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Caudal epidural injection

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

Group Type ACTIVE_COMPARATOR

Caudal epidural injection

Intervention Type PROCEDURE

Caudal epidural injection with catheterization

Percutaneous adhesiolysis

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

Group Type ACTIVE_COMPARATOR

Percutaneous adhesiolysis

Intervention Type PROCEDURE

Percutaneous adhesiolysis with hypertonic saline neurolysis

Interventions

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Caudal epidural injection

Caudal epidural injection with catheterization

Intervention Type PROCEDURE

Percutaneous adhesiolysis

Percutaneous adhesiolysis with hypertonic saline neurolysis

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No