Digitally Delivered Treatments to Reduce Chronic Low Back Pain

Официальное название

NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain

Обзор

This study aims to evaluate the effectiveness of pain education and clinical hypnosis delivered via a mobile app compared to a guideline-informed factsheet for reducing pain and disability in people experiencing chronic low back pain attending general practice.

Вмешательства

• Поведенческое Pain education and clinical hypnosis delivered via a mobile app
  Pain education and clinical hypnosis will be delivered via a mobile app. The 8-week intervention includes daily sessions on pain education and clinical hypnosis for managing back pain (5 minutes of education, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes). The first six weeks will be semi-standardised, with participants following a set program with the option to repeat sessions. The last two weeks will be flexible, allowing participants to
• Поведенческое Guideline-informed factsheet
  A single guideline-informed factsheet for back pain delivered via a webpage. Participants will be informed that the factsheet intends to provide reassurance for their back pain and encourage reflections on treatments and self-management options.

Первичные конечные точки

• Pain intensity [Срок оценки: Week 8 post-randomisation]
• Disability [Срок оценки: Week 8 post-randomisation]

Вторичные конечные точки (8)

• Pain intensity [Срок оценки: Weeks 12, 26 and 52 post-randomisation]
• Disability [Срок оценки: Weeks 12, 26 and 52 post-randomisation]
• Worst pain intensity [Срок оценки: Weeks 8, 12, 26 and 52 post-randomisation]
• Adverse events [Срок оценки: Week 8 post-randomisation]
• Health-related quality of life [Срок оценки: Weeks 8, 12, 26 and 52 post-randomisation]
• Global impression of change [Срок оценки: Weeks 8, 12, 26 and 52 post-randomisation]
• Anxiety symptoms [Срок оценки: Weeks 8, 12, 26 and 52 post-randomisation]
• Depression symptoms [Срок оценки: Weeks 8, 12, 26 and 52 post-randomisation]

Критерии участия

Критерии включения

• Experiencing non-specific chronic low back pain (LBP), defined as pain between the 12th rib and the buttock crease.
• LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
• Currently consulting with a general practitioner for their non-specific chronic LBP across Australia.
• Mean pain intensity score on the Numeric Rating Scale ≥ 3/10 in the past week.
• A score of at least moderate on question 8 of the physical functioning component of the SF-36 questionnaire.
• Access to a mobile device with minimal requirements to download the study app (300MB).
• An internet connection to access the mobile app functionalities.
• Able to understand English via reading and audio materials.

Критерии исключения

• Known or suspected specific spinal (e.g., radiculopathy, fracture) or specific non-spinal non- (e.g., tumour, infection) pathology.
• Less than six months post-spinal surgery.
• Scheduled for major surgery during the program or the follow-up period.
• Known or suspected serious psychiatric condition not being treated by a health professional that would impact adherence to the trial activities.
• Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).

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

Австралия · 1 центр

• Neuroscience Research Australia — Randwick

Идентификаторы

NCT: NCT06984354 · iRECS4383

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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