Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain

Официальное название

Effectiveness of Different Percutaneous Electrolysis Treatment Protocols Targeting the Upper Trapezius Muscle in Chronic Neck Pain: A Randomized Controlled Trial

Обзор

In the planned study, we aim to investigate the effectiveness of percutaneous electrolysis treatment applied to myofascial trigger points in the upper trapezius muscle in patients with chronic neck pain. Two different protocols, a low-intensity (0.5 mA × 90 s) and a high-intensity (3 mA × 3 s × 3 repetitions), will be compared in the study. Patients participating in the research will be randomized into 2 groups using a computer program. Stretching exercises targeting the upper trapezius muscle will be given to both groups as a home exercise program. In both groups, the percutaneous electrolysis treatment protocol will be performed on the active myofascial trigger points in the upper trapezius muscle on the 1st, 8th, and 14th days of treatment, using 0.3-millimeter acupuncture needles and an EPTE® percutaneous electrolysis device (Ionclinics \& A. Deionic SL, Valencia, Spain). The low-intensity (0.5 milliampere × 90 s) treatment protocol will be applied to Group 1, and the high-intensity (3 milliampere × 3 s × 3 repetitions) treatment protocol will be applied to Group 2. In the study, two different protocols, low-intensity (0.5 mA × 90 s) and high-intensity (3 mA × 3 s × 3 repetitions), will be compared. In this way, it is aimed both to obtain information about optimal dosing and to contribute to the literature for a frequently involved muscle such as the upper trapezius.

Вмешательства

• Устройство Low-Intensity Percutaneous Electrolysis of the Upper Trapezius
  Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A low-intensity protocol is used (0.5 mA for 90 seconds per session) on days 1, 8, and 14.
• Устройство High-Intensity Percutaneous Electrolysis of the Upper Trapezius
  Ultrasound-guided percutaneous electrolysis applied to the active myofascial trigger points of the upper trapezius muscle using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device. A high-intensity protocol is used (3 mA for 3 seconds, repeated 3 times per session) on days 1, 8, and 14.
• Другое Upper Trapezius Stretching Exercise Program
  Home-based stretching exercise program targeting the upper trapezius muscle throughout the treatment period in both groups.

Первичные конечные точки

• Change in Pain Intensity (VAS) [Срок оценки: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.]

Вторичные конечные точки (2)

• Change in Pressure Pain Threshold (Algometry) [Срок оценки: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.]
• Change in Functional Disability (Modified Neck Disability Index) [Срок оценки: Baseline (prior to the first treatment session), immediately after completion of treatment (after the third session, approximately 2 weeks from baseline), and 3 months after treatment initiation.]

Критерии участия

Критерии включения

Patients who agree to participate in the study, are between 18 and 70 years of age, have had symptoms for at least 3 months, and have chronic neck pain with active myofascial trigger points in the upper trapezius muscle will be included.

Критерии исключения

Patients with malignancy, active infection, a history of widespread inflammatory rheumatic disease or fibromyalgia, trauma, skin lesions, infection or open wounds at the myofascial trigger point region, coagulopathy, warfarin use, a history of spinal or shoulder disorders, previous neck or upper extremity surgery, acute illness, muscle diseases, epilepsy, use of sedative medications, needle phobia, previous dry needling treatment for myofascial pain, a cardiac pacemaker, metal implants in the treatment area, conditions that contraindicate physiotherapy such as pregnancy, or metal allergy will not be included in the study.

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

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Sivas Devlet Hastanesi — Sivas

Идентификаторы

NCT: NCT07294651 · EPTE-MAS-001-S

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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