Electrical stimulation for shoulder pain after stroke - Phase III

Recruiting

Phase N/A Results N/A

Trial Description

To determine the effectiveness of two types of electrical stimulation regimens in reducing chronic shoulder pain after stroke.

Interventions

  • Electrical stimulation Other
    Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.

Trial Design

Randomized, controlled, evaluator-blinded, multicenter trial.

Patient Involvement

Subjects will be assigned to receive either PENS or TENS treatment. PENS treatment involves the temporary insertion of fine-wire electrodes into the shoulder. TENS treatment requires the subject to place adhesive patch electrodes around the shoulder. All subjects will receive 6 hours of stimulation treatment a day for 7 weeks, and will attend 6 office visits. Brief weekly telephone interviews will occur during the treatment period and at end-of-treatment and 3 and 6-month follow-up periods.

Outcomes

Type Measure Time Frame Safety Issue
Primary Pain intensity as determined by Brief Pain Inventory.
Secondary Pain interference with daily function as determined by Brief Pain Inventory & quality of life as determined by EuroQol EQ-5D.

Sponsors

NIH Bethesda, MD & NeuroControl Corporation