NCT02893267Completed
Multimodal Treatment for Hemiplegic Shoulder Pain
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke survivors. HSP is associated with poor rehabilitation outcomes, including interference with activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for HSP have been proposed, most do not result in long-term relief of pain. The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only treatment to provide long-term relief of pain for those with HSP. However, physical therapy (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical community, the superiority of PNS to a course of PT must be demonstrated. The investigators completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus, the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice, may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS alone or PT alone. Mechanisms also will be explored.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 31 Aug 2016
- Start date
- Jan 2017
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- MetroHealth Medical Center
- Diseases
- Stroke
- NCT number
- NCT02893267
What you commit to
- Study type: Interventional
- Participants enrolled: 96
- From Jan 2017 to the primary completion date, 30 Sept 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- joint or overlying skin infection or history of recurrent skin infections;
- 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.);
Lab values
- bleeding disorder or international normalized ratio (INR) \> 3.0;
Other
- insensate skin;
- sensitivity to skin surface electrodes and/or medical-grade adhesives, gels, tapes;
- medical instability;
- pregnancy;
- severely impaired communication.
Who the study is looking for
- 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.
Age in the registry: 21 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolinas Rehabilitation Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Shirley Ryan AbilityLab Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.