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Идёт набор NCT03168802

MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

Без фазы С лечением Chronic Low Back Pain Facet Joint Syndrome

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: MRgFUS ablation, Radiofrequency ablation.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain, Facet Joint Syndrome. Базовые параметры: 20 лет — 79 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain

Обзор

This is a prospective, randomized, two-arm, phase II study. The purpose of this study is: * To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain. * Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment. * Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.

Вмешательства

  • Процедура MRgFUS ablation
    Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
  • Процедура Radiofrequency ablation
    Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.

Первичные конечные точки

  • Pain score change: Numerical Rating Scale (NRS) [Срок оценки: 24-week post-treatment]
Вторичные конечные точки (7)
  • Pain score change: Numerical Rating Scale (NRS) [Срок оценки: 1-, 4-, 8-, 12-, 36-, 52-week post-treatment]
  • Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL) [Срок оценки: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]
  • Functional scales change: Oswestry Disability Questionnaire (ODQ) [Срок оценки: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]
  • Functional scales change: Core Outcome Measurement Index (COMI) [Срок оценки: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]
  • Functional scales change: EQ5D Quality of Life questionnaires [Срок оценки: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]
  • Amount of analgesic consumption [Срок оценки: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]
  • Adverse event [Срок оценки: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]

Критерии участия

Критерии включения

  • Men and women age 20 to 79 years old
  • Suffering from lumbar vertebral facet joint syndrome.
  • Lower back pain at least six months (NRS≥4).
  • Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
  • Imaging of the spine have facet osteoarthritis.
  • Referred pain is no more below the knee.
  • At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction> 75% (0.5ml of 2% lidocaine).

Критерии исключения

  • Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
  • Patients with motor deficit or any other indication for surgical intervention.
  • Patients with MRgFUS or RF treatment for LBP within the last 6 months.
  • Patients with previous low back surgery.
  • Patients who are pregnant.
  • Patients with existing malignancy.
  • Patients with allergies to relevant contrast, anesthetics, sedation drugs.
  • Patients with contraindications for MRI.
  • Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
  • Patients with unstable cardiac status including:
  • Unstable angina pectoris on medication
  • Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
  • Patients with Severe Congestive Heart Failure, NYHA class 4.
  • Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
  • Patients with pacemaker
  • Patients with severe cerebrovascular disease (CVA within last 6 months)
  • Patients with severe hypertension (diastolic BP > 100 on medication)
  • Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  • Patients unable to communicate with the investigator and staff.
  • Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
  • Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
  • When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).

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

Тайвань · 1 центр
  • Taipei medical university hospital — Taipei

Публикации

  • Weeks EM, Platt MW, Gedroyc W. MRI-guided focused ultrasound (MRgFUS) to treat facet joint osteoarthritis low back pain--case series of an innovative new technique. Eur Radiol. 2012 Dec;22(12):2822-35. doi: 10.1007/s00330-012-2628-6. Epub 2012 Aug 31. PMID 22935902
  • Kaye EA, Monette S, Srimathveeravalli G, Maybody M, Solomon SB, Gulati A. MRI-guided focused ultrasound ablation of lumbar medial branch nerve: Feasibility and safety study in a swine model. Int J Hyperthermia. 2016 Nov;32(7):786-94. doi: 10.1080/02656736.2016.1197972. Epub 2016 Jul 21. PMID 27443328
  • Krug R, Do L, Rieke V, Wilson MW, Saeed M. Evaluation of MRI protocols for the assessment of lumbar facet joints after MR-guided focused ultrasound treatment. J Ther Ultrasound. 2016 Apr 6;4:14. doi: 10.1186/s40349-016-0057-8. eCollection 2016. PMID 27054038
  • Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2. PMID 26495910

Идентификаторы

NCT: NCT03168802 · N201609021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗