Electrical Stimulation for Hemiplegic Shoulder Pain


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- shoulder pain localized to the glenohumeral joint, subacromial area or deltoid insertion associated with any of the following conditions: a) rest; b) passive abduction or external rotation ROM; c) active abduction or external rotation ROM; or d) manual palpation
- weakness of shoulder abductors (≤4/5 on MRC if isolated movement is present)
- age ≥21-yrs
- time from stroke ≥ 3-mo
- shoulder pain onset after the most recent stroke
- duration of shoulder pain ≥ 3-mo
- severity of shoulder pain on BPI-SF 3 ≥4
- cognitive ability to fulfill study requirements [a) exhibit 3 object immediate and 30 minute recall; b) ability to use a numeric rating scale (using a 0-10 numeric rating scale) by correctly ranking the tightness they feel on the unaffected arm of 3 low-pressure inflations with a standard sphygmomanometer cuff which follow a predetermined sequence (20, 40 and 0 mm Hg); and c) ability to follow 3-stage commands]
- availability of a reliable adult who can check the skin and assist the participant with the treatment protocol
- willing and able to report severity of shoulder pain throughout the study period
- willing to make all scheduled study visits post-implantation.

Exclusion Criteria

- evidence of joint or overlying skin infection
- insensate skin
- >1 opioid or nonopioid analgesics daily for shoulder pain
- daily intake of pain medications for any other chronic pain
- intra-articular or subacromial steroid injections to the shoulder in the previous 12-wks
- botulinum toxin injection to the trapezius, pectoralis or subscapularis muscle in the previous 12-wks
- receiving physical or occupational therapies for shoulder pain
- physician-diagnosed shoulder pathology symptomatic within the 5 yrs prior to CVA
- bleeding disorder
- INR>3.0 for those on warfarin [INR>3.0]
- poorly controlled diabetes [HbA1c>7.0]
- medical instability
- pregnancy
- uncontrolled seizures (>1/mo for 6-mo)
- uncompensated hemi-neglect
- severely impaired communication
- moderate to severe depression
- other confounding conditions such as ipsilateral upper limb lower motorneuron lesion, Parkinson's Disease, spinal cord injury, traumatic brain injury or multiple sclerosis
- other medical issues such as complex regional pain syndrome, bicipital tendonitis, myofacial pain syndrome, etc.
- the following cardiac conditions: a) history of arrhythmia with hemodynamic instability, such as ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation; b) any implantable stimulator such as demand pacemakers or defibrillators; and c) valvular heart disease including artificial valves (due to risk of infection and endocarditis)
- likely non-compliance factors such as distance from the center, inadequate social support, or psychiatric/psychologic factors