N/A
N=96
Multimodal Treatment for Hemiplegic Shoulder Pain
Stroke · Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT02893267 ↗Enrolled (actual)
96
Serious AEs
10.4%
Results posted
Dec 2025
Primary outcome: Primary: Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline — 7.1; 7.4; 8.1; -2.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral Nerve Stimulation (Device); Physical Therapy (Other); Sham-PT (Other); Sham-PNS (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline |
7.1; 7.4; 8.1; -2.8; -2.4; -2.4 | — |
Summary
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.
Eligibility Criteria
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; 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 instability;
- pregnancy;
- uncontrolled seizures (>1/mo for 6-mo);
- history of cardiac arrhythmia with hemodynamic instability;
- history of lidocaine allergy;
- history of Parkinson's disease, spinal cord injury (SCI), traumatic brain injury (TBI), multiple sclerosis (MS), or ipsilateral upper extremity (UE) lower motor neuron lesion;
- history of complex regional pain syndrome, myofacial pain syndrome, other pain conditions (investigator discretion);
- cardiac pacemaker or other implanted electronic device;
- history of valvular heart disease (artificial valves, requiring antibiotics for procedures, etc.);
- severely impaired communication.
Data sourced from ClinicalTrials.gov (NCT02893267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.