Clinical trial NCT01094301: Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain
Official title: A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: electrical stimulation
neurostimulation
neuromodulation
shoulder pain
post-stroke shoulder pain
hemiplegic shoulder pain
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NDI Medical, LLC
First posted: 2010-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity (Trial Stage)
timeFrame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
measure: Pain Intensity (Implant Stage)
timeFrame: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)
measure: Device-Related Adverse Events
timeFrame: Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)
measure: Number of Subjects Who Were a Trial Stage Success
timeFrame: End of Treatment (EOT)
measure: Number of Subjects Who Were an Implant Stage Success
timeFrame: 12-weeks post IPG-Stim ON
Secondary outcomes:
measure: Pain Interference (Trial Stage)
timeFrame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
measure: Pain-Free Passive Range of Motion (Trial Stage)
timeFrame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage);
measure: Quality of Life (Trial Stage)
timeFrame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
measure: Number of Participants Completing the Economic Impact Survey
timeFrame: Baseline
measure: Emotional Functioning (Trial Stage)
timeFrame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
measure: User Satisfaction (Trial Stage)
timeFrame: 6-week (Trial Stage)
measure: Global Impact of Stimulation Therapy (Trial Stage)
timeFrame: 3-week (Trial Stage), 6-week (Trial Stage)
measure: Quality of Life (Implant Stage)
timeFrame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
measure: Pain Interference (Implant Stage)
timeFrame: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
measure: Pain-Free Passive Range of Motion (Implant Stage)
timeFrame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
measure: Emotional Functioning (Implant Stage)
timeFrame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
measure: Global Impact of Stimulation Therapy (Implant Stage)
timeFrame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)
measure: User Satisfaction (Implant Stage)
timeFrame: 12-weeks,12-months post IPG-Stim ON (Implant Stage)
measure: Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
timeFrame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System/Carolinas Rehabilitation
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Elkins Park
country: United States
facility: Moss Rehab/ Albert Einstein Healthcare Network
state: Pennsylvania
Study officials:
References:
citation: Nguyen VQ, Bock WC, Groves CC, Whitney M, Bennett ME, Lechman TE, Strother R, Grill JH, Stager KW, Chae J. Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil. 2015 Feb;94(2):146-53. doi: 10.1097/PHM.0000000000000173.