New combo therapy offers hope for stroke Survivors' shoulder pain
NCT ID NCT02893267
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two treatments for shoulder pain in people who had a stroke: a nerve stimulation technique and physical therapy. About 96 adults with lasting shoulder pain after a stroke took part. The goal was to see if combining both treatments works better than either one alone for long-term pain relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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96 people
The number who actually took part.
- Start date
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Jan 2017
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carolinas Rehabilitation
Charlotte, North Carolina, 28203, United States
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MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
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Shirley Ryan Abilitylab
Chicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next