Electrical Stimulation & Physical Therapy

Wilson_Shoulder_Pain-02 (003)Multimodal Treatment for Hemiplegic Shoulder Pain

 

Background

Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke survivors. HSP is associated with poor rehabilitation outcomes, including interference with activities of daily living and poor quality of life. While many treatments for HSP have been proposed, most do not result in long-term relief of pain.

The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic review of randomized controlled trials concluded that intramuscular PNS was the only treatment to provide long-term relief of pain for those with HSP. However, physical therapy (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical community, the superiority of PNS to a course of PT must be demonstrated. The investigators completed a pilot randomized controlled trial comparing PNS to PT and 67% vs. 25% of participants experienced successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively.


About This Study

Objective/Specific Aims: The primary objective of this 2-site randomized controlled trial is to confirm the findings of this preliminary pilot randomized controlled trial. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice, many have a synergistic therapeutic effect. Thus, the second objective of this trial is to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS alone or PT alone. Mechanisms also will be explored.

Study Information: This study employs the use of multiple modalities in order to determine the efficacy of combined PNS and PT in comparison to PNS in the absence of PT, or vice versa. The stimulation system includes an external stimulator, a percutaneous lead, and a pad. There is a 1-week stabilization period following the insertion of the percutaneous lead into the participant, after which stimulation is initiated. This treatment entails 6-hour stimulation sessions every day for 3 weeks. Total time of electrode implantation is no more than 29 days. Additionally, patients will participate in eight 60-minute outpatient physical therapy sessions over the course of 4 weeks, concurrent with PNS treatment.


Detailed program information and criteria available at:
https://clinicaltrials.gov/ct2/show/NCT02893267

Principal Investigator: Richard Wilson, M.D.
Contact: Peggy Maloney, R.N.
Contact Number: (216) 957-3558
Contact Email: mmaloney@metrohealth.org