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Intramuscular Electrical Stimulation for Hemiplegic Shoulder Pain: A 12-Month Follow-Up of a Multiple-Center, Randomized Clinical Trial

Chae, John MD, ME; Yu, David T. MD; Walker, Maria E. MSE; Kirsteins, Andrew MD; Elovic, Elie P. MD; Flanagan, Steven R. MD; Harvey, Richard L. MD; Zorowitz, Richard D. MD; Frost, Frederick S. MD; Grill, Julie H. MSE; Fang, Zi-Ping PhD

American Journal of Physical Medicine & Rehabilitation: November 2005 - Volume 84 - Issue 11 - p 832-842
doi: 10.1097/01.phm.0000184154.01880.72
Research Article: Stroke

Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP: Intramuscular electrical stimulation for hemiplegic shoulder pain: A 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil 2005;84:832–842.

Objective: Assess the effectiveness of intramuscular electrical stimulation in reducing hemiplegic shoulder pain at 12 mos posttreatment.

Design: A total of 61 chronic stroke survivors with shoulder pain and subluxation participated in this multiple-center, single-blinded, randomized clinical trial. Treatment subjects received intramuscular electrical stimulation to the supraspinatus, posterior deltoid, middle deltoid, and upper trapezius for 6 hrs/day for 6 wks. Control subjects were treated with a cuff-type sling for 6 wks. Brief Pain Inventory question 12, an 11-point numeric rating scale was administered in a blinded manner at baseline, end of treatment, and at 3, 6, and 12 mos posttreatment. Treatment success was defined as a minimum 2-point reduction in Brief Pain Inventory question 12 at all posttreatment assessments. Secondary measures included pain-related quality of life (Brief Pain Inventory question 23), subluxation, motor impairment, range of motion, spasticity, and activity limitation.

Results: The electrical stimulation group exhibited a significantly higher success rate than controls (63% vs. 21%, P = 0.001). Repeated-measure analysis of variance revealed significant treatment effects on posttreatment Brief Pain Inventory question 12 (F = 21.2, P < 0.001) and Brief Pain Inventory question 23 (F = 8.3, P < 0.001). Treatment effects on other secondary measures were not significant.

Conclusions: Intramuscular electrical stimulation reduces hemiplegic shoulder pain, and the effect is maintained for ≥12 mos posttreatment.

From the Cleveland Functional Electrical Stimulation Center, Cleveland, Ohio (JC, DTY); the Departments of Physical Medicine and Rehabilitation (JC, DTY) and Biomedical Engineering (JC), Case Western Reserve University, Cleveland, Ohio; Charlotte Institute for Rehabilitation, Charlotte, North Carolina (AK); Kessler Medical Rehabilitation Research and Education Corporation, West Orange, New Jersey (EPE); the Department of Rehabilitation Medicine, Mt. Sinai School of Medicine, New York, New York (SRF); Rehabilitation Institute of Chicago, Chicago, Illinois (RLH); the Department of Rehabilitation Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (RDZ); the Division of Physical Medicine and Rehabilitation, Cleveland Clinic Foundation, Cleveland, Ohio (FSF); and NeuroControl Corporation, Valley View, Ohio (MEW, JHG, ZPF).

All correspondence and requests for reprints should be addressed to John Chae, MD, ME, Department of Physical Medicine and Rehabilitation, Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, OH 44109.

Supported, in part, by grants R44HD34996 and K12HD01097 from the National Institute for Child Health and Human Development, grant M01RR0080 from the National Center for Research Resource, and by NeuroControl Corporation, Valley View, Ohio.

Dr. Yu is now affiliated with the Department of Rehabilitation Medicine, University of Washington, Seattle, Washington; Dr. Kirsteins is now affiliated with Moses Cones Health System, Greensboro, North Carolina; Ms. Maria Walker and Ms. Julie H. Grill are now affiliated with New Developments and Innovation in Medical Technology, Cleveland, Ohio.

Presented, in part, at the 65th Annual Assembly of the American Academy of Physical Medicine and Rehabilitation, November 2004, Tuscan, Arizona.

NeuroControl Corporation (NCC), Valley View, Ohio, intends to commercialize the device evaluated in this article. John Chae, MD, ME, and David Yu, MD, are consultants to NCC, which has a financial interest in the contents of this article. Zi-Ping Fang, PhD, is an employee of NCC. Maria Walker, MS, and Julie Grill, MS, were employees of NCC at the time of this clinical trial, but they are no longer affiliated with the company. Zi-Ping Fang, PhD, and Maria Walker, MS, are named on a patent for the device evaluated in this study.

FIM™ is a trademark of the Uniform Data System for Medical Rehabilitation, a division of UB Foundation Activities, Inc.

© 2005 Lippincott Williams & Wilkins, Inc.