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临床试验/NCT07063641
NCT07063641尚未招募不适用

Development of a Predictive Model to Identify Clinical Factors Associated With Response to Percutaneous Electrical Nerve Stimulation in Patients With Subacromial Pain Syndrome

Néstor Requejo Salinas0 个研究点目标入组 269 人开始时间: 2025年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
269
主要终点
Pain intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Pain intensity

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Néstor Requejo Salinas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Néstor Requejo Salinas

Principal Investigator, Department of Physiotherapy, University of Alcalá and Centro Superior Universitario La Salle

Centro Universitario La Salle

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