Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • The SPR System Device
    Intervention Desc: The SPR System is an investigational two-staged device which delivers stimulation to the muscles in the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.
    ARM 1: Kind: Experimental
    Label: The SPR System
    Description: The SPR System is an investigational two-staged device which delivers stimulation to the muscles in the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

Trial Design

  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Pain Intensity 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) No
Primary Device Related Adverse Events 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) Yes
Secondary Pain Interference 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) No
Secondary Pain-Free Passive Range of Motion 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) No
Secondary Quality of Life 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) No
Secondary Impact of Stimulation Therapy 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks,12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) No
Secondary Emotional Functioning 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) No
Secondary User Satisfaction 6-week (Trial Stage);12-weeks,12-months post IPG-Stim ON (Implant Stage) No
Primary Pain Intensity (Trial Stage Success) Baseline, 3-week (Trial Stage), 6-week (Trial Stage) No
Primary Pain Intensity (Implant Stage Success) 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) No
Secondary Economic Impact of Shoulder Pain Baseline No
Secondary Global Impact of Stimulation Therapy 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) No

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