A prospective nonrandomized clinical trial.
To determine the outcome in a group of patients with chronic, function-limiting low back pain who met the criteria for interbody fusion surgery, but were instead treated with an intradiscal thermal catheter (SpineCath, Oratec Interventions, Inc., Menlo Park, CA).
Summary of Background Data.
This study represents the first reported trial of treatment for chronic discogenic low back pain with a novel thermal intradiscal catheter.
The authors evaluated 25 consecutive patients. The minimum duration of nonoperative care with the authors was 6 months. The visual analog pain scores, sitting tolerance times, and SF-36 summary scores were tabulated.
The mean follow-up period was 7 months, and the mean duration of symptoms 58.5 months. Of the 25 patients, 20 (80%) reported a reduction of at least 2 points in visual analog pain scores, and 18 (72%) reported an improvement in sitting tolerance as well as reduction or discontinuance of analgesic medication. Visual analog pain scores improved by a mean reduction of 3.74, a 51% change (P
= 0.0001). On the SF-36 physical function subscale, 72% of the patients improved by a mean increase of 15 points (P
= 0.001), a mean change of 38%, and by a mean increase of 14 points on the bodily pain subscale (P
= 0.004), a mean change of 48%.
A statistically significant improvement in functional outcome was obtained in patients with chronic discogenic low back pain treated thermally by the SpineCath.