Predictive Model for PENS Response in Subacromial Pain Syndrome (NCT07063641) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Predictive Model for PENS Response in Subacromial Pain Syndrome
269 participantsStarted 2025-09-20
Plain-language summary
Subacromial pain syndrome (SPS) is one of the most common causes of shoulder pain, leading to significant disability and socioeconomic burden. Although percutaneous electrical nerve stimulation (PENS) targeting the suprascapular nerve (SN) has shown positive therapeutic outcomes, individual response to the intervention varies considerably. This study aims to develop a multivariable predictive model to estimate clinical response to SN-targeted PENS in patients with SPS. The model will be built using clinical, psychological, and neural mechanosensitivity variables. The goal is to enhance patient selection and guide personalized treatment strategies.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged between 18 and 65 years.
Clinical diagnosis of subacromial pain syndrome (SAPS), based on the following clinical criteria:
* Pain localized to the anterolateral shoulder region.
* Symptoms present for more than 6 weeks.
* Painful arc during shoulder abduction.
* Positive Neer or Hawkins-Kennedy impingement signs.
* Positive Jobe (empty can) test or external rotation resistance test.
Visual Analogue Scale (VAS) for shoulder pain ≥ 3/10 in the previous week.
Able to understand study procedures and sign informed consent.
Exclusion Criteria:
* Bilateral shoulder pain.
* History of fracture, dislocation, or surgical intervention on the affected shoulder.
* Presence of other shoulder pathologies such as adhesive capsulitis (frozen shoulder), glenohumeral instability, or full-thickness rotator cuff tear.
* Medical contraindications for PENS application (e.g., active anticoagulation, pregnancy, or decompensated psychiatric condition).
* Diagnosed cervical radiculopathy or myelopathy.
* Neurological or cognitive disorders interfering with study participation.
* Presence of chronic widespread pain syndromes, such as fibromyalgia.
* Belonephobia (severe needle phobia) that prevents intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.