Subacromial Pain SyndromeNCT07063641
Predictive Model for PENS Response in Subacromial Pain Syndrome
A study testing Percutaneous Electrical Nerve Stimulation (PENS) in people with Subacromial Pain Syndrome and Rotator Cuff Related Shoulder Pain, run by Néstor Requejo Salinas.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
- What is being tested?
- Percutaneous Electrical Nerve Stimulation (PENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Predictive Model to Identify Clinical Factors Associated With Response to Percutaneous Electrical Nerve Stimulation in Patients With Subacromial Pain Syndrome
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.
Read the detailed description
Subacromial pain syndrome (SPS) includes a group of clinical entities related to rotator cuff tendinopathy and subacromial structures that cause shoulder pain and functional limitations. PENS applied to the suprascapular nerve (SN) has demonstrated effectiveness in reducing pain and improving short-term function in patients with SPS. However, variability in clinical response suggests the influence of individual characteristics that are not yet well understood.
This study will conduct a prospective, single-arm, uncontrolled clinical trial involving 269 patients diagnosed with SPS. All participants will undergo a single ultrasound-guided session of PENS on the SN. The primary outcome will be post-treatment pain intensity measured with the Visual Analogue Scale (VAS). n addition to the primary outcome, several baseline variables will be collected to develop a multivariable beta regression predictive model. These variables include demographic data (age, sex, weight, height, BMI), clinical characteristics (pain duration in weeks, baseline pain intensity measured with the Visual Analogue Scale), psychological measures (Hospital Anxiety and Depression Scale - HADS), physical activity levels (International Physical Activity Questionnaire - Short Form), and measures of neural mechanosensitivity (pressure pain threshold on the infraspinatus and result of the suprascapular neurodynamic test). These predictors will be incorporated into the model regardless of their univariate significance, in line with best practices in predictive modelling.
A beta regression model will be developed to predict post-treatment pain intensity. Internal validation and model stability will be assessed using bootstrap resampling methods. This protocol follows the TRIPOD guidelines for clinical prediction model development.
Identifying reliable predictors of response will support clinical decision-making, helping to personalize physiotherapy approaches and improve the cost-effectiveness of SPS management. The findings may provide a robust foundation for future research and eventual clinical implementation of prediction tools for individualized therapy planning.
- Being tested
- Percutaneous Electrical Nerve Stimulation (PENS)
- Keywords
- Percutaneous Electrical Nerve Stimulation, Suprascapular Nerve, Neural Mechanosensitivity, Musculoskeletal Pain, Ultrasound-Guided Interventions, Subacromial pain syndrome
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Percutaneous Electrical Nerve Stimulation (PENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start20 Sep 2025 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Néstor Requejo Salinas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala, Centro Universitario La Salle
- Responsible party
- Sponsor-investigator, Néstor Requejo Salinas, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063641
- Sponsor's protocol ID
- PENS-SDS-UAH-2025
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Predictive Model to Identify Clinical Factors Associated With Response to Percutaneous Electrical Nerve Stimulation in Patients With Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT07063641
- Acronym / sponsor ID
- PENS-SDS-UAH-2025
- Keywords
- Percutaneous Electrical Nerve Stimulation, Suprascapular Nerve, Neural Mechanosensitivity, Musculoskeletal Pain, Ultrasound-Guided Interventions, Subacromial pain syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Néstor Requejo SalinasUniversity, hospital or other
- Collaborators
- University of Alcala, Centro Universitario La Salle
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subacromial pain syndrome (SPS) includes a group of clinical entities related to rotator cuff tendinopathy and subacromial structures that cause shoulder pain and functional limitations. PENS applied to the suprascapular nerve (SN) has demonstrated effectiveness in reducing pain and improving short-term function in patients with SPS. However, variability in clinical response suggests the influence of individual characteristics that are not yet well understood.
This study will conduct a prospective, single-arm, uncontrolled clinical trial involving 269 patients diagnosed with SPS. All participants will undergo a single ultrasound-guided session of PENS on the SN. The primary outcome will be post-treatment pain intensity measured with the Visual Analogue Scale (VAS). n addition to the primary outcome, several baseline variables will be collected to develop a multivariable beta regression predictive model. These variables include demographic data (age, sex, weight, height, BMI), clinical characteristics (pain duration in weeks, baseline pain intensity measured with the Visual Analogue Scale), psychological measures (Hospital Anxiety and Depression Scale - HADS), physical activity levels (International Physical Activity Questionnaire - Short Form), and measures of neural mechanosensitivity (pressure pain threshold on the infraspinatus and result of the suprascapular neurodynamic test). These predictors will be incorporated into the model regardless of their univariate significance, in line with best practices in predictive modelling.
A beta regression model will be developed to predict post-treatment pain intensity. Internal validation and model stability will be assessed using bootstrap resampling methods. This protocol follows the TRIPOD guidelines for clinical prediction model development.
Identifying reliable predictors of response will support clinical decision-making, helping to personalize physiotherapy approaches and improve the cost-effectiveness of SPS management. The findings may provide a robust foundation for future research and eventual clinical implementation of prediction tools for individualized therapy planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suprascapular Nerve PENS | Experimental | Device: Percutaneous Electrical Nerve Stimulation (PENS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Electrical Nerve Stimulation (PENS)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. | Device | Suprascapular Nerve PENS |
Primary outcome
Pain intensity
Time frame: 4 weeks post-intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Electrical Nerve Stimulation (PENS) in people with Subacromial Pain Syndrome and Rotator Cuff Related Shoulder Pain, run by Néstor Requejo Salinas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Néstor Requejo, PT (+34 917 40 19 80, nestor.requejo@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.