Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain.

OBJECTIVE

To obtain data on patient demographics, clinical practices, and long-term outcomes for patients with chronic low back pain treated with implantable drug-delivery systems.

DESIGN

The National Outcomes Registry for Low Back Pain collected data at baseline, trialing, implant (or decision not to implant), and at 6- and 12-month follow-ups. Data were collected at all time points, regardless of implant status.

OUTCOME MEASURES

Numeric pain ratings and Oswestry Low Back Pain Disability scores from implanted patients were compared among baseline and 6- and 12-month follow-ups. Patients were also asked to rate their quality of life and satisfaction with the therapy.

RESULTS

Thirty-six physicians enrolled 166 patients to be trialed for drug-delivery systems. The trialing success rate was 93% (154 patients). In all, 136 patients (82%) were implanted. In the implant group, numeric pain ratings dropped by more than 47% for back pain and more than 31% for leg pain at the 12-month follow-up. More than 65% of implanted patients reduced their Oswestry scores by at least one level at their 12-month follow-ups compared with baseline. At 12-month follow-ups, 80% of implanted patients were satisfied with their therapy and 87% said they would undergo the procedure again.

CONCLUSIONS

Current clinical practices related to trialing of drug-delivery systems resulted in the majority of patients successfully trialed. At 12-month follow-ups, implanted patients experienced reductions in numeric back and leg pain ratings, improved Oswestry scores, and high satisfaction with the therapy.