Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.

Официальное название

Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Right Shoulder Pain and Hepatobiliary Visceral Comorbidity.

Обзор

Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology.

Подробное описание

Approximately 80% of patients with liver disease suffer chronic pain and fatigue, which can lead to sensitization of the central and peripheral nervous system. Central sensitization is an increase in the responsiveness of neurons within the central nervous system, which can lead to generalized pain hypersensitivity. It has been shown that some lesions or inflammatory processes can trigger changes in the nervous system, generating persistent pain.

According to the theory of visceral referred pain, there are visceral and musculoskeletal stimuli that converge in higher centers capable of producing referred pain in regions where metameric innervation is shared. This raises the possibility that altered visceral mechanisms may provoke and chronify musculoskeletal pain.

According to this theory, people with structural or functional hepatobiliary pathologies may have referred pain in the right metameric territory of C2-C3-C4-C5, which may generate pain in the shoulder on the same side. This is due to the fact that the phrenic nerve sensitively innervates Glisson's capsule, so any affectation of this structure can generate afferent stimuli to the previously mentioned metameric levels.

The phrenic hypothesis plays a very important role today, having as its main "endorsement" the analgesic techniques of phrenic blockade used for shoulder pain after hepatectomy. In order to eliminate this post-operative shoulder pain, electrical or medical nerve blocks are used.

Вмешательства

• Устройство Phrenic nerve neuromodulation
  The intervention group will receive the usual physiotherapy treatment at the health center and will also receive neuromodulation on the phrenic nerve at its exit through the anterior cervical region. The neuromodulation technique will be applied for 10 minutes.
• Процедура common Physical therapy
  the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed.

Первичные конечные точки

• Numeric Pain Rating Scale [Срок оценки: pre-treatment, 1 week, 4 week, 12 week.]

Вторичные конечные точки (4)

• Algometry [Срок оценки: pre-treatment, 1 week, 4 week, 12 week.]
• Goniometry passive [Срок оценки: pre-treatment, 1 week, 4 week, 12 week.]
• Quick Dash questionnaire [Срок оценки: pre-treatment, 1 week, 4 week, 12 week.]
• Goniometriy active [Срок оценки: pre-treatment, 1 week, 4 week, 12 week.]

Критерии участия

Критерии включения

• Over 18 years of age.
• Subjects presenting right shoulder pain at the time of enrollment in the study.
• Presentation of a hepatobiliary visceral disorder that may justify the visceral etiology of the pain.
• That they agree to participate in the project by signing the informed consent form.

Критерии исключения

• Patients with chronic pain due to other diseases such as malignant disease.
• Patients with rheumatic diseases.
• Cutaneous infection in the area of pain.
• Disease of neurological, traumatic, oncologic, or infectious origin that rules out the visceral origin of the pain.
• Uncooperative subject.
• Severe psychiatric disease.
• Loss of cognitive capacity.
• Contraindication to electrotherapy.

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

Испания · 4 центра

• Centro de Salud Ronda Histórica — Seville
• Centro de Salud las Letanías — Seville
• Centro de Salud Bellavista — Seville
• Centro de especialidades Morón de la Frontera — Morón de la Frontera

Идентификаторы

NCT: NCT06296979 · 0881-N-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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