Treatment of chronic low back pain with successive injections of botulinum toxin a over 6 months: a prospective trial of 60 patients.

OBJECTIVES: The aim of this study was to evaluate the effects of two successive neurotoxin treatments for chronic low back pain using multiple pain rating scales in an open-label, prospective study.

METHODS: Adult patients with chronic low back pain received multiple paraspinal muscle injections with a maximum dosing of 500 units of botulinum A toxin per session. Those with a beneficial clinical response received a second treatment at 4 months. Pain was assessed by visual analog scale (VAS), modified low back pain questionnaire (OLBPQ), and a clinical low back pain questionnaire (CLBPQ) at baseline, 3 weeks, 2 months, 4 months, and 6 months after the first treatment.

RESULTS: Eighteen women and 42 men, ages 21 to 79 years (mean 46.6 years), with low back pain of a mean duration of 9.1 years were included. Significant improvement in back and radicular pain occurred at 3 weeks in 60% and at 2 months in 58% of the cohort. Beneficial clinical response to the first injection predicted response to reinjection in 94%. A significant minority of patients had a sustained beneficial effect from the first injection at 4 (16.6%) and 6 months (8.3%). Two patients had a transient flu-like reaction after the initial treatment.

CONCLUSIONS: Botulinum toxin A improves refractory chronic low back pain with a low incidence of side effects. The beneficial clinical response is sustained with a second treatment.