Идёт набор NCT07373210
Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy
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: Open-Label Placebo, Treatment as usual.
- Кому может быть актуально
- Состояния в реестре: Periacetabular Osteotomy, Opiates. Базовые параметры: 13 лет — 40 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)
Обзор
In this randomized controlled trial, 64 participants undergoing PAO at UCSF will be enrolled and randomized to receive either COLP plus treatment as usual (TAU) or TAU alone. Patients in the COLP arm will receive placebo pills alongside prescribed opioids and at scheduled intervals, beginning on postoperative day one. Weekly follow-up will be conducted for six weeks postoperatively via remote surveys and video visits.
Вмешательства
- Другое Open-Label Placebo
One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1. - Другое Treatment as usual
Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1.
Первичные конечные точки
- Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU) [Срок оценки: Admission to 6 weeks post-operatively]
- To determine if 6 weeks of COLP results in reduced pain perception compared with TAU. [Срок оценки: Admission to 6 weeks post-operatively.]
Вторичные конечные точки (6)
- Duration of time in days following surgery until patients establish independence with physical therapy [Срок оценки: Post-operative Day 1 to 6 weeks.]
- Length of hospital stay [Срок оценки: Admission to discharge, up to 6 weeks]
- Time to return to school or work [Срок оценки: Discharge to first day of school or work, up to 6 weeks post-operatively]
- Urinary retention [Срок оценки: During hospitalization, until discharge, up to 6 weeks]
- Constipation & First Bowel Movement [Срок оценки: Post-operatively to first flatus and bowel movement, up to 6 weeks]
- Number of postoperative clinical contacts in COLP compared to TAU [Срок оценки: Post-operatively to 6 weeks]
Критерии участия
Критерии включения
- Aged 13 to 40 years old, and
- Undergo primary Bernese Periacetabular osteotomy (PAO) for symptomatic developmental dysplasia of the hip (DDH), and
- Opioid-naïve prior to operation, and
- Capable of completing study procedures, including daily pain and medication diaries as well as weekly questionnaires.
Критерии исключения
- Undergoing PAO revision or any concurrent major surgical procedure
- History of opioid use, substance use disorders, or alcohol abuse
- Those with cognitive or physical impairments that would interfere with providing their own consent and the completion of study-related tasks
- Pregnant individuals or those planning to become pregnant during the study period
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 California San Francisco — San Francisco
Публикации
- Furie KS, James K, Kaptchuk TJ, Diab M. Effectiveness of conditioning + open-label placebo for post-operative pain management in adolescent idiopathic scoliosis. Pain Manag. 2025 Jul;15(7):363-371. doi: 10.1080/17581869.2025.2520148. Epub 2025 Jun 19. PMID 40536435
- Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700. PMID 27755279
- Blease C, Colloca L, Kaptchuk TJ. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations. Bioethics. 2016 Jul;30(6):407-14. doi: 10.1111/bioe.12245. Epub 2016 Feb 3. PMID 26840547
- von Wernsdorff M, Loef M, Tuschen-Caffier B, Schmidt S. Effects of open-label placebos in clinical trials: a systematic review and meta-analysis. Sci Rep. 2021 Feb 16;11(1):3855. doi: 10.1038/s41598-021-83148-6. PMID 33594150
- Kirchhof J, Petrakova L, Brinkhoff A, Benson S, Schmidt J, Unteroberdorster M, Wilde B, Kaptchuk TJ, Witzke O, Schedlowski M. Learned immunosuppressive placebo responses in renal transplant patients. Proc Natl Acad Sci U S A. 2018 Apr 17;115(16):4223-4227. doi: 10.1073/pnas.1720548115. Epub 2018 Apr 2. PMID 29610294
- Ader R, Mercurio MG, Walton J, James D, Davis M, Ojha V, Kimball AB, Fiorentino D. Conditioned pharmacotherapeutic effects: a preliminary study. Psychosom Med. 2010 Feb;72(2):192-7. doi: 10.1097/PSY.0b013e3181cbd38b. Epub 2009 Dec 22. PMID 20028830
- Doering BK, Rief W. Utilizing placebo mechanisms for dose reduction in pharmacotherapy. Trends Pharmacol Sci. 2012 Mar;33(3):165-72. doi: 10.1016/j.tips.2011.12.001. Epub 2012 Jan 25. PMID 22284159
- Sandler AD, Glesne CE, Bodfish JW. Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder? J Dev Behav Pediatr. 2010 Jun;31(5):369-75. doi: 10.1097/DBP.0b013e3181e121ed. PMID 20495473
Идентификаторы
NCT: NCT07373210 · 25-44743