Predictive Model for PENS Response in Subacromial Pain Syndrome

ConditionsSubacromial Pain Syndrome Rotator Cuff Related Shoulder Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorNéstor Requejo Salinas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

Percutaneous Electrical Nerve Stimulation (PENS)
Device
Ultrasound-guided percutaneous electrical nerve stimulation applied to the suprascapular nerve using a monophasic or biphasic current at 10 Hz frequency and 250 μs pulse width. Intensity is progressively increased to patient tolerance, aiming to induce visible muscle contractions of the supraspinatus and infraspinatus. Duration of the session is 30 minutes.

Treatment groups

269 Participants

are divided into 1 treatment group

Group A: Suprascapular Nerve PENSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pain intensity

Pain intensity will be measured with a 100 mm Visual Analogue Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). This is the primary outcome used to evaluate the clinical response to a single ultrasound-guided session of percutaneous electrical nerve stimulation (PENS) targeting the suprascapular nerve in patients with subacromial pain syndrome. This outcome will be used as the dependent variable in the multivariable predictive model.

Time frame

4 weeks post-intervention

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Néstor Requejo Salinas

Lead sponsor

Centro Universitario La Salle

Sponsor institution

University of Alcala

Collaborator