Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke survivors. HSP is associated with poor rehabilitation outcomes, including interference with activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for HSP have been proposed, most do not result in long-term relief of pain.
The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only treatment to provide long-term relief of pain for those with HSP. However, physical therapy (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical community, the superiority of PNS to a course of PT must be demonstrated. The investigators completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus, the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice, may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS alone or PT alone. Mechanisms also will be explored.
Who can participate
Age range
21 Years – 89 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:
* shoulder pain localized to the glenohumeral joint, subacromial area or deltoid insertion associated with: a) rest; b) passive abduction or external rotation range of motion (ROM); c) active abduction ROM; or, d) manual palpation;
* shoulder pain onset or worsening after the most recent stroke;
* weakness of shoulder abductors (≤4/5 on Medical Research Council (MRC) scale if isolated movement is present);
* ≥ 21-yrs old; \< 90-yrs old;
* time of stroke ≥ 3-mo;
* duration of HSP ≥3-mo;
* HSP with moderate to severe pain (BPI SF-3 ≥ 4);
* cognitive and communication ability to fulfill study requirements (cognitive ability based upon a score of ≥24 on the Mini Mental Status Exam (MMSE));
* availability of reliable adult who can assist with study procedures if necessary;
* willing and able to report shoulder pain and other conditions and complete study visits throughout the 4 month study period.
Exclusion Criteria:
* joint or overlying skin infection or history of recurrent skin infections;
* insensate skin;
* need to take \> 1 opioid and \> 1 nonopioid analgesic medication for HSP;
* regular intake of pain medications for another chronic pain;
* botox injection or subacromial steroid injections to the shoulder within the past 12 weeks;
* receiving occupational therapy (OT) or PT for HSP;
* bleeding disorder or international normalized ratio (INR) \> 3.0;
* sensitivity to skin surface electrodes and/or medical-grade adhesives, gels, tapes;
* medical instab…
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.
What they're measuring
1
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline
Timeframe: Baseline, 4 weeks(end of treatment), 16 weeks, 28 weeks