Predictive Model for PENS Response in Subacromial Pain Syndrome

NCT07063641 | Not Yet Recruiting

• 1 other identifier: PENS-SDS-UAH-2025
• Study Type: interventional
• Target: 269
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Subacromial Pain Syndrome; Rotator Cuff Related Shoulder Pain

Keywords

Percutaneous Electrical Nerve Stimulation; Suprascapular Nerve; Neural Mechanosensitivity; Musculoskeletal Pain; Ultrasound-Guided Interventions; Subacromial pain syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks post-intervention

Study Arms (1)

Suprascapular Nerve PENS

EXPERIMENTAL

Participants in this arm will receive a single ultrasound-guided session of percutaneous electrical nerve stimulation (PENS) targeting the suprascapular nerve. The procedure involves needle placement adjacent to the suprascapular nerve and electrical stimulation for 30 minutes.

Device: Percutaneous Electrical Nerve Stimulation (PENS)

Interventions

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.

Suprascapular Nerve PENS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Néstor Requejo Salinas: lead
• University of Alcala: collaborator
• Centro Universitario La Salle: collaborator

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Néstor Requejo, PT

CONTACT

+34 917 40 19 80; nestor.requejo@lasallecampus.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Physiotherapy, University of Alcalá and Centro Superior Universitario La Salle

Model Details: Uncontrolled, single-arm clinical trial aimed at developing a multivariable predictive model of response to suprascapular nerve-targeted PENS in patients with subacromial pain syndrome.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07