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Идёт набор NCT07269925

Impact of Different Electrical Frequencies Used in Percutaneous Neuromodulation on Muscle Strength and Pressure Pain Thresholds

Без фазы С лечением Shoulder Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Percutaneous electrical nerve stimulation: High frequency, Percutaneous electrical nerve stimulation: Low frequency.
Кому может быть актуально
Состояния в реестре: Shoulder Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Percutaneous electrical nerve stimulation (PENS) involves delivering electrical currents through fine filiform needles inserted near tissues such as muscles, ligaments, or nerves. It has been explored for various chronic pain conditions affecting the cervical and lumbar spine, as well as the upper and lower limbs. Despite its growing clinical use, the overall quality of evidence supporting PENS for chronic musculoskeletal pain remains limited. Most studies have applied the technique directly over nerve structures, and while some reviews have shown greater pain reduction compared to transcutaneous electrical nerve stimulation (TENS), the superiority of PENS has not been conclusively demonstrated. Research specifically examining its application on nerve tissues, particularly in the upper limbs, remains scarce. Some preliminary and single-case studies have reported improvements in pain and disability following PENS directed at the radial nerve, but these findings are limited by small sample sizes and the absence of control groups. The physiological mechanisms underlying PENS are still not fully understood, though both peripheral and central processes are believed to be involved. Evidence suggests that PENS can reduce local sensitivity to pressure pain through peripheral mechanisms and may also enhance descending inhibitory control by activating conditioned pain modulation at the central level. However, further studies are necessary to clarify these effects. Since to date, limited research has specifically examined the optimal PENS dosage, the present study aimed to compare two PENS dosage for improving muscle strength and pain pressure thresholds.

Вмешательства

  • Другое Percutaneous electrical nerve stimulation: High frequency
    A single PENS session will be applied under ultrasound guidance using sterile, single-use filiform needles placed in the suprascapular and axillary nerves and connected to an electrostimulator APSe4 (Agupunt, Barcelona). Dosage will be: 100 Hz frequency, 250 µs pulse width, 5-second stimulation followed by 55-second rest, repeated five times
  • Другое Percutaneous electrical nerve stimulation: Low frequency
    A single PENS session will be applied under ultrasound guidance using sterile, single-use filiform needles placed in the suprascapular and axillary nerves and connected to an electrostimulator APSe4 (Agupunt, Barcelona). Dosage will be: 2 Hz frequency, 250 µs pulse width, 10 minutes duration, with an intensity (mA) sufficient to elicit a visible motor response while remaining comfortable for the patient.

Первичные конечные точки

  • Muscle strength [Срок оценки: Baseline]
  • Muscle strength [Срок оценки: Post-intervention (10 minutes)]
Вторичные конечные точки (4)
  • Pain Pressure Thresholds - Latent MTrP [Срок оценки: Baseline]
  • Pain Pressure Thresholds - Latent MTrP [Срок оценки: Post-intervention (10 minutes)]
  • Pain Pressure Thresholds - Tibialis anterior [Срок оценки: Baseline]
  • Pain Pressure Thresholds - Tibialis anterior [Срок оценки: Post-intervention (10 minutes)]

Критерии участия

Критерии включения

  • Presence of at least one latent myofascial trigger point (MTrP) in the infraspinatus muscle, identified according to the most recent Delphi consensus criteria.
  • Ability to read, understand, and sign the written informed consent form.

Критерии исключения

  • Current pharmacological treatment that may affect muscle tone.
  • History of shoulder or spinal surgery.
  • Traumatic disorders such as whiplash-associated injuries, dislocations, or fractures.
  • Neuropathies, including radiculopathies or myelopathies.
  • Severe medical conditions (e.g., tumors, fractures, neurological or systemic diseases).
  • Clinically relevant asymmetries.
  • Generalized musculoskeletal conditions such as fibromyalgia.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Польша · 2 центра
  • ATMIS — Krakow
  • ATMIS — Nowy Targ

Идентификаторы

NCT: NCT07269925 · UComplutenseMadrid-PENS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗