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Набор скоро начнётся NCT06546462

Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?

Без фазы С лечением Headache Disorders Headache Analgesia Opioid Use

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: Osteopathic Manipulative Treatment (OMT), Sham Light touch arm.
Кому может быть актуально
Состояния в реестре: Headache Disorders, Headache, Analgesia, Opioid Use. Базовые параметры: 18 лет — 75 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
США
Следующий шаг
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Официальное название

Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?

Обзор

The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.

Подробное описание

The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol (OMT) or light touch protocol in reducing headache frequency and the use of pain medication for headache pain. Previous research has suggested that OMT may alleviate headache symptoms. This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications, including over-the-counter medications, migraine-specific treatments, and opioids. The study consists of a ten-week period, including 2 weeks of observation, 6 weeks of intervention, and 2 weeks of washout. Participants will be randomly assigned to either receive OMT or a light touch protocol. Investigators will compare questionnaires assessing quality of life and functionality scales. Pain levels and medication use will be logged daily throughout the study.

Вмешательства

  • Другое Osteopathic Manipulative Treatment (OMT)
    The active arm will receive osteopathic manipulative treatment which is a hands-on treatment modality use to treat a variety of health concerns.
  • Другое Sham Light touch arm
    Sham arm will receive a light touch sham treatment.

Первичные конечные точки

  • Change in pain levels [Срок оценки: Assessment of weekly average pain from week 1 till week 10 end of the study period]
  • Change in analgesia use [Срок оценки: Assessment of weekly amount of pain medications used from week 1 till week 10 end of the study period]
Вторичные конечные точки (3)
  • Change in quality of Life - Headache disability index [Срок оценки: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)]
  • Change in quality of Life - Headache Impact Test (HIT-6) [Срок оценки: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)]
  • Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL) [Срок оценки: To be completed at Week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)]

Критерии участия

Критерии включения

  • 18 to 75 years of age
  • takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).
  • 3 months or greater history of headaches or migraines
  • Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT

Критерии исключения

  • current diagnosis of neoplasm
  • history of headache secondary to trauma or concussion
  • history of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)
  • acute psychiatric diagnosis
  • pregnancy
  • history of substance use disorder

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

США · 1 центр
  • Riland Academic Health Care Center — Old Westbury

Публикации

  • Jara Silva CE, Joseph AM, Khatib M, Knafo J, Karas M, Krupa K, Rivera B, Macia A, Madhu B, McMillan M, Burtch J, Quinonez J, Albert T, Khanna D. Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. Cureus. 2022 Aug 9;14(8):e27830. doi: 10.7759/cureus.27830. eCollection 2022 Aug. PMID 36110479
  • Chin J, Qiu W, Lomiguen CM, Volokitin M. Osteopathic Manipulative Treatment in Tension Headaches. Cureus. 2020 Dec 12;12(12):e12040. doi: 10.7759/cureus.12040. PMID 33457139

Идентификаторы

NCT: NCT06546462 · Headache OMT · BHS-1852

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗