An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Str… (NCT00567541) | Clinical Trial Compass
CompletedPhase 2
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
United States16 participantsStarted 2007-06
Plain-language summary
The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Chronic post-stroke duration greater than or equal to 6 months
* Unilateral hemiplegic shoulder pain persisting for ≥6 months
* Hemiparesis (shoulder abduction graded \<5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has chronic pain
* Shoulder pain ≥ 6/10 (on 0-10 numeric rating scale (NRS) for worst pain in last week (BPI #12))
* Ability to give informed consent and understand study requirements
* Ability to quantify pain using a 0-10 numeric rating scale. (A screening tool will be used to ensure that participants can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other.)
* Willing and able to understand and comply with all study-related procedures during the course of the study
* Motivated to maintain an accurate diary for the study duration
Exclusion Criteria:
* Hemineglect (i.e., extinguish to double simultaneous stimulation)
* Shoulder trauma or diagnosed shoulder pathology prior to stroke; history of any shoulder surgery, regardless of whether procedure preceded for followed stroke.
* Need to take \>1 pain medication (opioid or non-opioid) for shoulder pain
* Regular use of pain medication for chronic pain other than shoulder pain
* Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
* Unable, per their prescribing physician, to stop antiplatelet medications (e.g., aspirin, ticlopi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.