Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatments percutaneous adhesiolysis with hypertonic saline neurolysis, rk needle and racz catheter system, local anesthetic, steroid, 10% sodium chloride solution
Sponsor Pain Management Center of Paducah
Start date January 2006
End date December 2009
Trial size 320 participants
Trial identifier NCT00370994, protocol 11

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

Measure
To assess adverse events in both groups.
time frame: 3, 6, 12, 18 and 24 months post treatment.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis
Principal investigator Laxmaiah Manchikanti, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Pain Management Center of Paducah.