Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02893267
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; \< 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
89 Years
Study:
NCT02893267
Study Brief:
Protocol Section:
NCT02893267