Prospective Clinical Study of a New Implantable Peripheral Nerve Stimulation Device to Treat Chronic Pain
- 1 June 2010
- journal article
- clinical trial
- Published by Ovid Technologies (Wolters Kluwer Health) in The Clinical Journal of Pain
- Vol. 26 (5), 359-372
- https://doi.org/10.1097/ajp.0b013e3181d4d646
Abstract
To evaluate clinical use of the StimRouter, an investigational implanted peripheral nerve stimulator for treating chronic neuropathic pain, using the median nerve as a model for that general application. Eight patients with carpal tunnel syndrome and chronic pain despite both carpal tunnel release and treatment with oral pain medications were enrolled in a single-center, open-label trial after institutional review board approval. Primary endpoints were successful implantation near the target peripheral nerve and safety. All 8 patients were implanted temporarily at the median nerve in at least one arm and 2 patients were implanted bilaterally, with 10 implants total. Each implant was considered a separate “patient.” For 5 days, all patients received 6 hours of daily transdermal electrical stimulation targeting the median nerve. Pain was measured at baseline, during implant, and after explant. Two patients experienced clinically meaningful (≥30%) pain reduction throughout the entire 5-day treatment period. Apparent carryover effect in pain reduction also was observed after daily stimulation. After explant, pain returned to baseline, increasing 36.8% to 45.6% relative to average reduced pain with daily stimulation. No significant or unexpected adverse events occurred. Mean patient study satisfaction was 96%, and 100% of patients indicated a preference for permanent implant. Temporary implant of the StimRouter device resulted in both pain reduction and reduced use of oral opioid pain medication during the 5-day stimulation period. The results suggest that permanent implant of the StimRouter System may be safe and effective for treating chronic peripheral neuropathic pain.Keywords
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