Clinical Trial: Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain

Brief Summary:

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the muscles in the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.

Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.


Detailed Summary:
Sponsor: SPR Therapeutics, LLC

Current Primary Outcome:

  • Pain Intensity (Trial Stage Success) [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage) ]
    Change in pain intensity
  • Device Related Adverse Events [ Time Frame: Baseline, 48-hour visit, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ]
  • Pain Intensity (Implant Stage Success) [ Time Frame: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ]
    Change in pain intensity


Original Primary Outcome:

  • Pain Intensity [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ]
  • Device Related Adverse Events [ Time Frame: Baseline, 48-hour visit, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ]


Current Secondary Outcome:

  • Pain Interference [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ]
  • Pain-Free Passive Range of Motion [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • Quality of Life [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • Economic Impact of Shoulder Pain [ Time Frame: Baseline ]
  • Emotional Functioning [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • User Satisfaction [ Time Frame: 6-week (Trial Stage);12-weeks,12-months post IPG-Stim ON (Implant Stage) ]
  • Global Impact of Stimulation Therapy [ Time Frame: 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage) ]


Original Secondary Outcome:

  • Pain Interference [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ]
  • Pain-Free Passive Range of Motion [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • Quality of Life [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • Impact of Stimulation Therapy [ Time Frame: 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks,12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • Emotional Functioning [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ]
  • User Satisfaction [ Time Frame: 6-week (Trial Stage);12-weeks,12-months post IPG-Stim ON (Implant Stage) ]


Information By: SPR Therapeutics, LLC

Dates:
Date Received: March 25, 2010
Date Started: April 2010
Date Completion:
Last Updated: January 25, 2017
Last Verified: January 2017