Shoulder pain following stroke is a major rehabilitation problem affecting approximately 60% of moderate to severely impaired stroke survivors. The investigative team demonstrated the efficacy of short-term, percutaneous intramuscular (IM) peripheral nerve stimulation (PNS) in treating shoulder pain following stroke. However, only those individuals who received treatment within 18 months of their stroke experienced enduring treatment effect. Those treated after 18 months experienced significant pain reduction at the end of treatment, but pain returned within 3 months. To treat this more challenging population, an exploratory placebo controlled, randomized controlled trial is proposed to demonstrate the safety and efficacy of a fully implantable PNS System. The trial has 2 stages. During the Trial Stage, participants who experience benefit from short-term percutaneous IM PNS, but in whom pain returns are identified. During the Implant Stage, these participants receive the fully implanted IM PNS system and are randomized to receive IM PNS or a second course of short-term percutaneous IM PNS treatment. Outcomes include pain, motor impairment, ADLs and quality of life. In order to explore mechanisms, participants in both Stages undergo quantitative sensory and motor testing.

Public Health Relevance

Shoulder pain following stroke is a major rehabilitation problem affecting approximately 60% of all moderate to severely impaired stroke survivors, and is associated with poor recovery, impaired activities of daily living and reduced quality of life. This project will evaluate the effectiveness of a novel fully implanted peripheral nerve stimulatio treatment for reducing post-stroke shoulder pain.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD075542-01A1
Application #
8578038
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Michel, Mary E
Project Start
2013-09-06
Project End
2018-05-31
Budget Start
2013-09-06
Budget End
2014-05-31
Support Year
1
Fiscal Year
2013
Total Cost
$505,291
Indirect Cost
$157,042
Name
Case Western Reserve University
Department
Physical Medicine & Rehab
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106