Stroke Programs

Electrical Stimulation for Treatment of Stroke Shoulder Pain

Utilizing percutaneous stimulation, this program is evaluating relief from chronic shoulder pain.

General Information on this clinical study

Principal Investigator: John Chae, M.D.

Clinical Coordinator: Peggy Maloney, R.N.

Contact Number: 216-778-8563

Contact Email: mmaloney@metrohealth.org

Program Title: Electrical Stimulation for Treatment of Stroke Shoulder Pain

Purpose

Hemiplegic shoulder pain is a considerable problem in stroke rehabilitation and may influence a patient's functional recovery and quality of life after a stroke. Researchers at MetroHealth Medical Center in conjunction with NeuroControl Corporation are conducting a study which assesses the safety and effectiveness of percutaneous electrical stimulation and surface electrical stimulation to treat chronic stroke shoulder pain. Pain intensity and how shoulder pain affects daily living will be assessed throughout the 9 month study period.

Description

The multi-site randomized clinical trial will involve a total of 112 participants with chronic, moderated to severe shoulder pain. The study will take place at six sites throughout the United States. Subjects enrolled will be stroke survivors with sustained hemiplegic shoulder pain 3 months duration or more, with or without shoulder joint subluxation. Pain score rating for this pain is 4 or greater, using the Numerical Rating Scale (0 to 10). Upon enrollment, participants will be prescribed a standardized home exercise program which involves range-of motion and strengthening movements to be performed daily to the affected shoulder. Based on current medication for shoulder pain, these individuals will be prescribed up to 2 types of medication for their pain. An MRI of the affected shoulder will be performed upon enrollment to diagnose the degree of rotator cuff tears, if present. Study subjects will be assigned to receive either percutaneous or surface stimulation. These individuals will be asked to return for 5 office visits after the enrollment process. Each group will receive 6 weeks of stimulation to the affected shoulder. The prescription for daily stimulation treatment will consist of two 3-hour sessions with at least 3 hours of rest between sessions. The surface group will be able to use the surface stimulator beyond the last visit, up to the 6-month timepoint. Outcome measures will be assessed by using the Brief Pain Inventory (BPI) and EuroQol questionnaire through weekly phone interviews. Shoulder pain interference with quality of life and daily living is assessed. The study protocol for each subject takes a total of 35 weeks from the enrollment to the completion of follow-up pain assessments.