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Набор скоро начнётся NCT06077526

Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department

Без фазы С лечением Chronic Pain

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: P.E.A.K. Rx, Usual Care.
Кому может быть актуально
Состояния в реестре: Chronic Pain. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Alleviating Burden of Chronic Musculoskeletal Pain in the Emergency Department: P.E.A.K. Rx Feasibility Trial

Обзор

Chronic musculoskeletal pain (CMP) and lack of physical activity often co-exist, contributing to increased disability, non-communicable diseases (e.g., obesity, diabetes, hypertension), psychological comorbidity (e.g., anxiety and depression), and healthcare utilization and costs \[1-6\]. Many individuals with CMP seek assistance at emergency departments (ED). ED overuse has been an ongoing concern, with 1-in-5 Americans presenting to the ED at least once each year \[7\]. Of these visits, 24 million are for adults seeking help for chronic pain, with an additional 12 million due to exacerbations of an existing chronic pain condition \[8\]. In 2021, the fourth most common reason for seeking care in the ED related to a primary diagnosis involving the musculoskeletal system, with an estimated 9.5 million visits \[9\]. Most ED visits result in a 'treat and release' approach, potentially disrupting continuity of care and resulting in follow-up ED visits \[10\]. These ED visits for chronic pain are indicative of accessibility problems to community-based primary and preventative care, compounded by limited or no health insurance coverage \[10\]. Based on the Emergency Medical Treatment and Labor Act, EDs are required to stabilize all patients regardless of ability to pay \[10\]. To alleviate the burden of CMP on patients and EDs, improve access to quality healthcare, and mitigate initial and repeat ED visits, alternative options are required. Here we propose a novel group-based intervention involving pain education (PE) and physical activity (PA) implemented in CMP patients presenting to the ED of a community level hospital. The investigators will recruit 60 adults from a community hospital located in the Shenandoah Valley region of Virginia; participants will be randomized to either Pain Education and Active Knowledge (P.E.A.K.) Rx (24 sessions of group PE+ + PA) or usual care. Research assessments are conducted with both groups at study entry (baseline), 8-weeks, 3-months, and 6-months.

Вмешательства

  • Поведенческое P.E.A.K. Rx
    Pain Education + Physical Activity Group Based Intervention
  • Другое Usual Care
    Participants will receive the community hospital's usual care.

Первичные конечные точки

  • Visual Analog Scale [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
Вторичные конечные точки (7)
  • Tampa Scale of Kinesiophobia [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Pain Catastrophizing Scale [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Patient Specific Functional Scale (PSFS) [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Saltin-Grimby physical activity scale for leisure time physical activity [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • 36-Item Short Form Health Survey (SF-36) [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Self-report physical exercise [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]
  • Self-report occupational activity [Срок оценки: Baseline, post-intervention 8-weeks, 3-months, and 6-months]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Sedentary (e.g., not meeting PA guidelines, assessed by ACSM PA vitals)
  • English speaking and reading comprehension
  • Not currently pregnant
  • Diagnosed with CMP based on electronic health record:
  • Non-red flag presentation (e.g., red flags: current fracture, malignancy, infection, vascular issues, or in need of surgical intervention).
  • Persistent or recurrent pain for 3+ months, with at least moderate pain intensity level (Visual Analog Scale of 40/100)

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06077526 · 23-010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗