Magnetic Resonance Elastography of Myofascial Pain Syndrome

Обзор

The purpose of this research study is to use a new imaging technique called Magnetic Resonance (MR) Elastography to create new imaging parameters to measure the mechanical properties of myofascial tissues that can be used to assess the impaired myofascial interface in myofascial pain syndrome (MPS).

Подробное описание

This is observational research that aims to develop an MRI-based imaging technique (MRE) to quantitatively assess the myofascial tissue properties in healthy subjects and patients with relevant pain conditions. Healthy volunteers and patients with MPS will be recruited to undergo MRI along with MR elastography.

Вмешательства

• Диагностический тест Magnetic Resonance (MR) Elastography
  Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
• Диагностический тест MRI structural imaging
  MRI structural imaging will be done at the same time as MR elastography.

Первичные конечные точки

• The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements [Срок оценки: baseline measures through the study completion (3 years)]

Критерии участия

Healthy Volunteer Inclusion Criteria:

• Absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work
• A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale)
• Able to understand the goal of the project and give informed consent.

Healthy Volunteer Exclusion Criteria:

• Pregnancy or breastfeeding
• Any contraindication to an MRI exam
• Previous severe/acute back or low extremity injury (including fracture)
• Previous back or low extremity surgery
• Back and lower limb deformities
• Inability to provide consent.

Myofascial-Related Pain Patient Inclusion Criteria:

• A history of chronic low back or leg pain (the targeted location will be determined based on the findings in Aim 1) for at least 3 months. (Measured by patient history and physical exam)
• A palpable taut band or nodule within the skeletal muscle
• Hypersensitive tender spot within the taut band
• Recognition of current pain complaint by pressure on the tender nodule/taut band
• Painful limit to the full stretch range of motion

Myofascial-Related Pain Patient Exclusion Criteria:

• Pregnancy or breastfeeding
• Any contraindication to an MRI exam
• Previous therapy in the area to be treated within 6 months
• Previous severe back or low extremity injury (including fracture) or surgery
• Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
• Severe osteoarthritis
• Skin injuries in the area to be treated
• Inability to provide consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Mayo Clinic Minnesota — Rochester

Идентификаторы

NCT: NCT05604066 · 22-007647 · R61AT012185

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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