INTRADISCAL NAVIGABLE CATHETER USED IN THE TREATMENT OF DISCOGENIC LOW BACK PAIN: 12 MONTH RESULTS

Abstract

To investigate the efficacy of the navigable intradiscal catheter in the treatment and relief of lumbar discogenic back pain.

Twenty-three (23) consecutive patients, at this site, were enrolled into the study by this investigator from normal practice. Inclusion criteria included presentation with predominant low back pain with or without referral leg pain lasting longer than 6 months, diagnosis of DDD or IDD confirmed by plain x-rays, MRI, and positive, low pressure discography, and failure of at least 6 weeks conservative treatment. Outcomes were assessed by clinical exam and administration of the SF-36 Health Survey during the baseline, 3, 6, and 12 month visits.

All treatments were performed on an outpatient basis. Following the administration of conscious sedation and local anesthetic, a 17-gauge introducer needle was placed by an extrapedicular approach into the symptomatic disc using fluoroscopic x-ray guidance. A navigable catheter was placed circumferentially to the posterior annular wall. Treatment time was 17 minutes at a maximum tissue temperature of approximately 90°C. Intradiscal antibiotics were employed post procedure and all patients were discharged the day of procedure without complications.

Thirty-three (33) lumbar discs were treated. Ten patients had single levels treated; thirteen had double levels treated. Twelve month results show significant improvements in pain as measured by a visual analogue scale (56% decrease, p = 0.035), and the SF-36 sub-scales measuring Bodily Pain (93% decrease, p = 0.011 at 6 months), Physical Functioning (65% increase, p = 0.035), and Role Physical (173% increase, p = 0.020). Overall, 80% of the patients were satisfied with their outcomes (p = 0.004).

The intradiscal navigable catheter has proven to be effective in the reduction of pain and an increase in functional abilities for patients who suffer discogenic low back pain due to IDD or DDD.