Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

Completed

Phase N/A Results N/A

Update History

15 Sep '17
The Summary of Purpose was updated.
New
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.
Old
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.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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
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
23 Sep '16
A location was updated in New York.
New
The overall status was removed for Weill Cornell Medical Center.
A location was updated in Charlotte.
New
The overall status was removed for Carolinas Healthcare System/Carolinas Rehabilitation.
A location was updated in Cleveland.
New
The overall status was removed for MetroHealth Medical Center.
A location was updated in Elkins Park.
New
The overall status was removed for Moss Rehab/ Albert Einstein Healthcare Network.
19 Feb '16
A location was updated in Charlotte.
New
The overall status was removed for Carolinas Healthcare System/Carolinas Rehabilitation.
A location was updated in Elkins Park.
New
The overall status was removed for Moss Rehab/ Albert Einstein Healthcare Network.
14 Oct '15
The Summary of Purpose was updated.
New
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.
Old
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.
8 Feb '14
The Summary of Purpose was updated.
New
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.
Old
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 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. This research study lasts a little over 3 years and includes 15 visits to the study doctor and 6 telephone calls from study staff.
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - At least 21 years of age - Post-stroke shoulder pain Exclusion Criteria: - Use of habit-forming (narcotic) medications - Poorly controlled diabetes - Bleeding disorder - Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, MS, or complex regional pain syndrome - Heart arrhythmia or artificial heart valves - Uncontrolled seizures - Implanted Electronic Device
5 Oct '12
A location was updated in Elkins Park.
New
The overall status was removed for Moss Rehab/ Albert Einstein Healthcare Network.
25 Sep '12
A location was updated in Charlotte.
New
The overall status was removed for Carolinas Healthcare System/Carolinas Rehabilitation.
23 Feb '12
A location was updated in New York.
New
The overall status was removed for Weill Cornell Medical Center.