EXTRACORPOREAL SHOCKWAVE THERAPY FOR THE TREATMENT OF INTERDIGITAL NEUROMA: A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL

Morton’s Neuroma is a common condition, often requiring surgical intervention. The success rate for resolution of symptoms, without complications, is commonly reported to be 85%. Complications can include stump neuroma, adhesive neuritis, and chronic pain syndrome. Endoscopic decompression of the neuroma has been reported but there have been no randomized and blinded studies reported to date. Extracorporeal Shockwave Treatment (ESWT) has a reported complication of nerve injury during treatment for certain musculoskeletal disorders. The purpose of this study is to evaluate the safety and effectiveness of ESWT to destroy a Morton’s neuroma as a therapeutic treatment. MATERIALS AND METHODS 25 patients (25 feet) were recruited and consented to take part in a placebocontrolled and blinded study for evaluation of the efficacy and safety of ESWT to ablate a Morton’s neuroma which was confirmed clinically and via ultrasound. Indications for participation were >8 months of conservative care with a visual analog pain score (VAS) of > 6. The mean time with pain was 41.6 months (range 10-120 months). The mean overall pain VAS was 7.5 (6-10). The ESWT procedure was performed under intravenous sedation (IVS) and local anesthetic (LA) using Marcaine 0.5%. Following IVS and LA, subjects were randomly assigned to an active or sham treatment group. The active group was treated with an Ossatron® (Healthtronics) device using 2000 pulses @ 21 Kv directed inferior to the neuroma. The sham foot received no treatment. 14 subjects were randomized to the active group and 11 to the sham group. Post treatment evaluations were carried out at 1, 6, and 12 weeks by a blinded investigator. End point evaluation parameters were reduction in VAS and Roles-Maudsley quality of life assessment.