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Идёт набор NCT05843890

Tailored Pain Guide (TPG) Study

Без фазы С лечением Chronic Lower Back 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: Structured and tailored PainGuide, Standard PainGuide.
Кому может быть актуально
Состояния в реестре: Chronic Lower Back 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
США
Следующий шаг
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Обзор

This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. This research will try to understand how much an electronic, self-management website like PainGuide can help participants. The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.

Подробное описание

There was an amendment approved by the University of Michigan Medical School Institutional Review Board (AME00158411). This amendment included the following:

increased enrollment numbers, updated recruitment procedures including the Non-Pharma Program (NPP) Sub-Study, as well as changes in time frames.

Вмешательства

  • Поведенческое Structured and tailored PainGuide
    Participants will receive specific instruction to complete one module a week over the first 4 weeks. Participants will then receive tailored messaging using scores from the assessments completed during T1(baseline visit) from the PROMIS 29+2. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks. The NPP Participants will be asked to complete surveys for 52 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuid
  • Поведенческое Standard PainGuide
    Participants in the control group will not receive any messaging once enrolled. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks. The NPP Participants will be asked to complete surveys for 52 weeks. All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).

Первичные конечные точки

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score [Срок оценки: Baseline, Week 24]
Вторичные конечные точки (10)
  • Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 [Срок оценки: Baseline, Week 24 (initial group), Week 52 (NPP group)]
  • Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 - between baseline and 52 weeks for NPP participants [Срок оценки: Baseline, Week 52 (T5)]

Критерии участия

Критерии включения

  • Chronic Lower Back pain (cLBP) defined by the National Institutes of Health (NIH) Task Force Report on Research Standards for Chronic Low Back Pain, (i.e., low back pain present at least six months, and present more than half of those days.)
  • Individuals must have a score of greater or equal to (≥) 60 on PROMIS Pain Interference.
  • Non-Pharma Sub-study:
  • Must be referred and currently on the waitlist for the NPP at the Back \& Pain Center (BPC)

Критерии исключения

  • Current cancer related pain
  • Diagnosis of autoimmune disease
  • Unable to speak, write or read English
  • Visual or hearing difficulties
  • Pregnancy or breastfeeding
  • Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

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

США · 1 центр
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT05843890 · HUM00214375

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗