Shoulder pain following stroke is a major rehabilitation problem affecting approximately 60% of moderate to severely impaired stroke survivors. While many treatments for HSP have been proposed, most do not result in long-term relief of pain. Our long-term goal is to develop a therapeutic intervention to reduce pain related to HSP. In a systematic review of randomized controlled trials, intramuscular peripheral nerve stimulation (PNS), developed by our research group, was the only treatment to provide long-term relief of pain for those with HSP. Our recent pilot RCT compared PNS to physical therapy (PT) and 67% vs. 25% of participants experienced successful pain relief (i.e., ? 2-pt or 30% reduction) from PNS and PT, respectively. Although PNS produced better outcomes than PT, there was still a large percentage of non-responders (50%) in the study. Furthermore, amongst responders, pain relief was incomplete in 63% of the PNS group and 100% in the PT group. Yet, both treatments did produce pain relief in a significant number of participants. Thus, a complementary, multimodal treatment of PNS + PT may increase the percentage of patients who experience significant pain relief and will produce a greater reduction in pain than with PNS or PT alone. The primary objective of this study is to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS or PT alone. The secondary objective is to investigate mechanisms of pain reduction by PNS and PT. In order to accomplish these objectives, the investigators designed a multi-site, placebo controlled, double-blinded RCT to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS or PT alone. Measures of pain, pain interference with ADLs, QoL, shoulder biomechanics (shoulder abduction torque, shoulder kinematics, and Fugl-Meyer score), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be measured. Participants will be followed for a total of 24 weeks after treatment has concluded.

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 multimodal treatment approach that includes intramuscular peripheral nerve stimulation combined with physical therapy, compared to each alone.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD084564-04
Application #
9761854
Study Section
Biobehavioral and Behavioral Sciences Subcommittee (CHHD)
Program Officer
Marden, Susan F
Project Start
2016-09-01
Project End
2022-05-31
Budget Start
2020-06-01
Budget End
2021-05-31
Support Year
4
Fiscal Year
2020
Total Cost
Indirect Cost
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