Peripheral Nerve Stimulation for Shoulder Pain: Dose Response
Completed · Not applicable
Conditions studied: Stroke, Shoulder Pain
In brief
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.
Key facts
- Study ID
- NCT02928055
- Run by
- MetroHealth Medical Center
- People needed
- 23
- Starts
- 2016-10-01
- Expected to finish
- 2019-10-30
- Last updated by the study team
- 2021-06-18
Who can join
Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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; < 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.
You may not qualify if…
- 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 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.
Where it is running
- MetroHealth Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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