NCT01123382

Electrical Stimulation for Hemiplegic Shoulder Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain has been difficult. In order to address the limitations of surface ES, the investigative team pioneered the development of percutaneous intramuscular (IM) ES for the treatment of post-stroke shoulder pain. However, prior to acceptance by the clinical community, additional gaps in the scientific and clinical knowledge need to be addressed. This study begins to do so. The primary objective is to estimate the relative pain reduction associated with IM ES vs. "usual care." We hypothesize that the IM ES group will exhibit a larger effect size with respect to pain reduction compared to "usual care". A secondary objective is to estimate the effect on health related QOL of IM ES vs. "usual care." Demonstration of improvement in QOL will validate the clinical relevance of the intervention. We hypothesize that the IM ES group will exhibit greater improvement in health related QOL compared to "usual care".

Conditions

• Stroke
• Shoulder Pain

Interventions

Type	Name	Description
DEVICE	Intramuscular Electrical Stimulator	A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed. Total time of electrode implantation is no more than 29 days.
OTHER	Outpatient Therapy	Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-05-14
• Last updated: 2018-01-23
• Results posted: 2017-12-12

Locations

1 site across 1 country: United States