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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43NS066524-01A1
Application #
7998307
Study Section
Special Emphasis Panel (ZRG1-MOSS-F (15))
Program Officer
Porter, Linda L
Project Start
2010-08-05
Project End
2012-03-31
Budget Start
2010-08-05
Budget End
2012-03-31
Support Year
1
Fiscal Year
2010
Total Cost
$303,701
Indirect Cost
Name
Ndi Medical, LLC
Department
Type
DUNS #
103621566
City
Cleveland
State
OH
Country
United States
Zip Code
44122
Nguyen, Vu Q C; Bock, William C; Groves, Christine C et al. (2015) Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil 94:146-53