Neuromodulation for Stroke Shoulder Pain

Ndi Medical, Llc, Cleveland OH

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): Shoulder pain is a common complication following stroke. A prospective population-based study on first-time stroke patients found that almost one third of patients developed shoulder pain, most describing their pain as moderate to severe. The treatment of shoulder pain is a crucial step towards recovery for stroke survivors. Shoulder pain has been found to lengthen the time to recovery, produce insomnia, and require additional medications or interventions during rehabilitation. The primary objective of this Phase I project is to determine the feasibility of a novel treatment for post-stroke shoulder pain using percutaneous intramuscular electrical stimulation. The first specific aim of this project is to determine the feasibility of the approach. The second specific aim is to evaluate the effect of percutaneous intramuscular electrical stimulation on shoulder pain intensity. The feasibility of reducing pain with intramuscular electrical stimulation will be assessed through the administration of a validated pain questionnaire. Endpoints will be measured at baseline, during and directly following the sham period, and during and directly following the treatment period. A multi-center randomized clinical trial will be executed in a Phase II project. The results of this randomized trial will be used to design a larger pivotal study that will be used to support an FDA pre-market approval (PMA) application for product commercialization. Our long-term objective is to develop a safe and effective neuromodulation treatment for patients with post-stroke shoulder pain. PUBLIC HEALTH RELEVANCE: Each year in the United States, almost one third of the 695,000 new stroke survivors develop shoulder pain, most describing their pain as moderate to severe. The treatment of shoulder pain is an important step towards recovery for stroke survivors, as shoulder pain has been found to interfere with therapeutic exercises, lengthen the time to recovery, produce insomnia, and require additional medications or interventions during rehabilitation. We propose to develop a novel therapy that uses electrical stimulation to treat post-stroke shoulder pain.