Re-engineering Precision Therapeutics Through N-of-1 Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Mean System Usability Score
研究概览
简要总结
The Personalized Trial of Chronic Lower Back Pain will test the feasibility of employing technology to facilitate remote N-of-1 interventions to research participants with self-identified back pain. Participants will spend 14 weeks alternating between massage, yoga, and usual care methods to treat their back pain, while answering daily questions and wearing an activity tracker. After 14 weeks, participants will have the ability to share their opinions about a Personalized Trials platform. We believe a Personalized Trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.
详细描述
The Personalized Trial of Chronic Lower Back Pain will facilitate remote N-of-1 interventions to research participants with self-identified back pain persisting longer than 12 weeks. Participants will be randomized in a multiple crossover design to receive Swedish massage in-home by a commercial wellness service, yoga instruction in-home by a commercial wellness service, and no intervention/usual care. Participants will evaluate their pain intensity, pain interference, fatigue and stress daily through self-reported questionnaires. Online screening and enrollment methods, text-message reminders and questionnaire prompts, and wearable devices will be employed to collect data. At the end of the study, participants will receive a personalized report summarizing their observed data in each treatment period. Participants will evaluate the system usability of Personalized Trials, will debrief their experience with a member of the research team, and will share their overall satisfaction with Personalized Trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •At least 18 years of age
- •Fluent in English
- •Experiencing symptoms of low back pain for > 12 weeks
- •Self-reported pain intensity > 8 on the PROMIS pain intensity scale during screening
- •Able to receive massage and yoga interventions (2x/week between 8 am and 10 pm)
- •Owns and can regularly access a smartphone capable of receiving text messages
- •Owns and can regularly access an e-mail account
排除标准
- •Pregnant women
- •History of spinal surgery
- •Complex back pain (e.g. sciatica, spinal stenosis, or other pre-existing condition)
- •Previous diagnosis of a serious mental health condition or psychiatric disorder
- •Previous diagnosis of opioid use disorder or treatment for any substance use disorder
- •Previously advised that yoga or massage is unsafe for their condition
- •Current opioid use
- •Current physical activity restrictions
- •Planned surgery or procedures within 6 months of recruitment
- •Planned travel outside the United States within treatment period time-frame
- •Weight greater than or equal to 500 lbs.
结局指标
主要结局
Mean System Usability Score
时间窗: Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion
Usability of the Personalized Trials platform will be evaluated using the System Usability Scale (SUS), a 10-item questionnaire created by Digital Equipment Co Ltd. and John Brooke in 1986 that asks users to score each item on a Likert scale from Strongly Disagree (1) to Strongly Agree (5). Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together. Higher scored values correlate to a more usable system, and therefore a better outcome.
次要结局
- Mean Participant Satisfaction with Personalized Trials Components(Assessed once after the results report has been sent to the participant, within 8 weeks of intervention completion)
- Mean Within-Subject Difference in Self-Reported Daily Pain Intensity During 3 Treatment Periods from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6)
- Mean Within-Subject Difference in Self-Reported Daily Pain Interference During 3 Treatment Periods from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6)
- Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Pain During 3 Treatment Periods from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6)
- Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Fatigue During 3 Treatment Periods from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6)
- Mean Within-Subject Difference in Ecological Momentary Assessment Three-Times-Daily of Stress During 3 Treatment Periods from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6)
- Mean Within-Subject Difference in Self-Reported Use of Pain Medication from Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6)
- Mean Within-Subject Difference in Device-Recorded Daily Steps from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.)
- Mean Within-Subject Difference in Device-Recorded Nightly Sleep from Mean Baseline(From 2-Week Treatment Period 1 to 2-week Treatment Period 6. Data collection to end after these 12 weeks.)
研究者
Karina Davidson
Senior Vice President of Research
Northwell Health