NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The statistician will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Pain education and clinical hypnosis delivered via a mobile app
Pain education and clinical hypnosis for self-managing back pain, delivered via a mobile app.
干预措施: Pain education and clinical hypnosis delivered via a mobile app (Behavioral)
Guideline-informed factsheet
A guideline-informed factsheet for back pain, delivered via a webpage.
干预措施: Guideline-informed factsheet (Behavioral)
结局指标
主要结局
Pain intensity
时间窗: Week 8 post-randomisation
Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)
Disability
时间窗: Week 8 post-randomisation
Disability will be measured using the Roland-Morris Disability Questionnaire scale, ranging from 0 to 24, with higher scores representing higher levels of disability.
次要结局
- Pain intensity(Weeks 12, 26 and 52 post-randomisation)
- Disability(Weeks 12, 26 and 52 post-randomisation)
- Worst pain intensity(Weeks 8, 12, 26 and 52 post-randomisation)
- Adverse events(Week 8 post-randomisation)
- Health-related quality of life(Weeks 8, 12, 26 and 52 post-randomisation)
- Global impression of change(Weeks 8, 12, 26 and 52 post-randomisation)
- Anxiety symptoms(Weeks 8, 12, 26 and 52 post-randomisation)
- Depression symptoms(Weeks 8, 12, 26 and 52 post-randomisation)
研究者
James McAuley
Principal Investigator
Neuroscience Research Australia