Phase
Condition
Stroke
Cerebral Ischemia
Treatment
Physical Therapy
Sham-PNS
Peripheral Nerve Stimulation
Clinical Study ID
Ages 21-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
shoulder pain localized to the glenohumeral joint, subacromial area or deltoidinsertion associated with: a) rest; b) passive abduction or external rotation rangeof 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 ifisolated 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 abilitybased 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 studyvisits throughout the 4 month study period.
Exclusion
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 12weeks;
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 motorneuron lesion;
history of complex regional pain syndrome, myofacial pain syndrome, other painconditions (investigator discretion);
cardiac pacemaker or other implanted electronic device;
history of valvular heart disease (artificial valves, requiring antibiotics forprocedures, etc.);
severely impaired communication.
Study Design
Study Description
Connect with a study center
Shirley Ryan Abilitylab
Chicago, Illinois 60611
United StatesSite Not Available
Carolinas Rehabilitation
Charlotte, North Carolina 28203
United StatesSite Not Available
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
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