N/A
N=23
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response
Stroke · Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT02928055 ↗Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Jun 2021
Primary outcome: Primary: Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) — 5.6; 6; 5.67; 6.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral Nerve Stimulation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) |
5.6; 6; 5.67; 6.5; 5.2; 4.4 | — |
Summary
The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain (HSP) reduction due to treatment with peripheral nerve stimulation. We will explore the association of subject-specific clinical and demographic information and pain relief from PNS. We will explore the possible role of central sensitization mechanisms in perpetuating pain via measures of sensory and pain perception. Lastly, we will explore the dose-response association of muscle-contraction from PNS and pain reduction, completion of activities of daily living (ADLs), and improvement in quality of life.
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 MRC 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 wks;
- receiving OT or PT for HSP;
- bleeding disorder or 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, SCI, TBI, MS, or ipsilateral 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 (NCT02928055). 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.