Overview

This trial is active, not recruiting.

Condition shoulder pain
Treatment the spr system
Sponsor NDI Medical, LLC
Start date April 2010
End date June 2018
Trial size 45 participants
Trial identifier NCT01094301, NDI-0122-CSP-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
the spr system
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.

Primary Outcomes

Measure
Pain Intensity (Trial Stage Success)
time frame: Baseline, 3-week (Trial Stage), 6-week (Trial 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)
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)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 21 years old.

Trial Stage Inclusion Criteria: - At least 21 years of age - Post-stroke shoulder pain Trial Stage Exclusion Criteria: - Use of habit-forming (narcotic) medications - History of recurrent skin infections - Bleeding disorder - Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome - Heart arrhythmia or artificial heart valves - Uncontrolled seizures - Implanted Electronic Device Implant Stage Inclusion Criteria - Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4

Additional Information

Official title A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by NDI Medical, LLC.