Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Pain, Enjoyment and General Activity (PEG) scores
研究概览
简要总结
Researchers are exploring how certain personal factors, such as symptoms, health history, and lifestyle, may help predict which treatments will work best for someone.
The purpose of this study is to evaluate how well a study algorithm chooses the best treatments for a patient when considering their unique pain characteristics.
详细描述
During the treatment stages participants may be placed into the following interventions:
- Physical Therapy & Exercise -10, standardized sessions over 8 weeks delivered individually and in-person by a physical therapist
- Duloxetine - FDA approved for musculoskeletal pain, self-administered SNRI medication taken daily over 8 weeks.
- Acupressure- a mobile health program- self-administered mHealth program with daily practice over 8 weeks.
- PRISM- cognitive-behavioral therapy plus resilience training- 8, weekly, digitally delivered pain self-management modules with corresponding weekly 15-minute standardized telehealth coaching sessions.
After participants are placed in an initial assignment based on a combination of the use of the phenotype based algorithm and randomization, they have the option of continuing on that treatment, switching to another (to be assigned by another randomization combined with use of the algorithm) or adding a second treatment to the first (to be assigned by another randomization combined with use of the algorithm).
Analysis of results will not be a function of the arms listed here, but on whether those allocations were based on the algorithm assigning them initially to their presumed "most effective" treatment; or to a potentially less effective treatment (2nd, 3rd or 4th, choice). These "ranked phenotypic" assignments are masked from participants and researchers until after the trial is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In ADAPT, participants are blinded to whether they are assigned to the Restricted Random Assignment (RRA) group or the Phenotype-Informed Assignment (PIA) group. Participants are only informed of their treatment assignment not assignment type.
Internally, the study team refers to the two study groups as "Maize" and "Blue" to maintain blinding.
In the consent form, the study team does not explicitly describe the two assignment groups. Instead, the study team explains that an algorithm will be used to help determine treatment assignment.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet the definition of Chronic Low Back Pain (cLBP) described in the NIH Task Force Report on Research Standards for cLBP, i.e., low back pain present at least six months, and present more than half of those days.2
- •Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference. The normal population mean for pain interference is
- •Participants must be 1 standard deviation (SD) above the population mean (>=60) for inclusion.
- •Individuals must be willing and eligible to receive at least three of the four proposed interventions.
- •Able to stand for at least 10 minutes
排除标准
- •Red flags suggesting the presence of an identifiable cause of low back pain, including fever, weight loss, initiation of pain following major trauma, immunosuppression, IV drug use, recent bacterial infection, severe or persistent sensory or motor involvement of bowel, bladder, or lower extremity.
- •Unable to read, write of speak fluent English
- •Visual or hearing difficulties that would preclude participation
- •Active uncontrolled drug/alcohol addiction
- •Individuals receiving new disability or compensation or involved in litigation in the past 12 months.
- •Pregnancy or breastfeeding
- •Individuals on high doses of opioids (over 100 Oral Morphine Equivalents [OME] per day).
- •Upcoming scheduled back surgery, back surgery within the last year, or more than one back surgery in the past.
- •History of discitis osteomyelitis (spine infection) or spine tumor
- •History of an autoimmune disorder such as ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
- •History of cauda equina syndrome or spinal radiculopathy
- •Diagnosis of schizophrenia or schizoaffective diagnosis
- •Diagnosis of any vertebral fracture in the last 6 months
- •Osteoporosis requiring treatment (vitamin D and calcium supplements are acceptable)
- •History of any bone-related cancer or cancer that metastasized to the bone
- •Currently in treatment for cancer or plan to start cancer treatment in the next 12 months
- •History of any cancer treatment in the last 24 months
- •Life expectancy is less than 2 years
- •Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
- •Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or recent suicide attempts
研究组 & 干预措施
Physical Therapy & Exercise then add Acupressure
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise then add Acupressure
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Physical Therapy & Exercise and continue
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise and continue
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Physical Therapy & Exercise followed by Duloxetine
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise followed by Duloxetine
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Physical Therapy & Exercise followed by PRISM-CBT
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise followed by PRISM-CBT
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Physical Therapy & Exercise followed by Acupressure
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise followed by Acupressure
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Physical Therapy & Exercise then add Duloxetine
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise then add Duloxetine
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Physical Therapy & Exercise then add PRISM-CBT
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Physical Therapy & Exercise then add PRISM-CBT
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Duloxetine and Continue
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Duloxetine followed by Physical Therapy & Exercise
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Duloxetine followed by PRISM-CBT
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Duloxetine followed by PRISM-CBT
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
Duloxetine then add Physical Therapy & Exercise
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Duloxetine then add Physical Therapy & Exercise
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Duloxetine then add PRISM-CBT
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Duloxetine then add Acupressure
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Duloxetine then add Acupressure
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Duloxetine then add Acupressure
干预措施: Duloxetine (Drug)
PRISM-CBT and continue
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT followed by Physical Therapy & Exercise
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT followed by Physical Therapy & Exercise
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
PRISM-CBT followed by Physical Therapy & Exercise
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT followed by Duloxetine
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT followed by Duloxetine
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT followed by Acupressure
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT followed by Acupressure
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT followed by Acupressure
干预措施: mHealth Acupressure Self-Management: (Behavioral)
PRISM-CBT then add Physical Therapy & Exercise
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT then add Physical Therapy & Exercise
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
PRISM-CBT then add Physical Therapy & Exercise
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT then add Duloxetine
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT then add Duloxetine
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT then add Acupressure
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Acupressure then continue
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure then continue
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Acupressure followed by Duloxetine
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Acupressure followed by PRISM-CBT
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure followed by PRISM-CBT
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
Acupressure followed by PRISM-CBT
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Acupressure then add Physical Therapy & Exercise
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure then add Physical Therapy & Exercise
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Acupressure then add Physical Therapy & Exercise
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Acupressure then add Duloxetine
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Acupressure then add PRISM-CBT
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure then add PRISM-CBT
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Duloxetine followed by Acupressure
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure followed by Physical Therapy & Exercise
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure followed by Physical Therapy & Exercise
干预措施: Physical Therapy (PT) and Exercise (Behavioral)
Acupressure followed by Physical Therapy & Exercise
干预措施: mHealth Acupressure Self-Management: (Behavioral)
Duloxetine then add PRISM-CBT
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT and continue
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
PRISM-CBT then add Acupressure
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
PRISM-CBT then add Acupressure
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
Acupressure followed by Duloxetine
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure then add Duloxetine
干预措施: Algorithmically informed randomization (taking into account phenotypes) (Device)
Acupressure then add PRISM-CBT
干预措施: Cognitive-Behavioral Therapy for Pain (PRISM-CBT) (Behavioral)
Duloxetine followed by PRISM-CBT
干预措施: Duloxetine (Drug)
Physical Therapy & Exercise followed by Duloxetine
干预措施: Duloxetine (Drug)
Physical Therapy & Exercise then add Duloxetine
干预措施: Duloxetine (Drug)
Duloxetine followed by Physical Therapy & Exercise
干预措施: Duloxetine (Drug)
Duloxetine then add PRISM-CBT
干预措施: Duloxetine (Drug)
Duloxetine and Continue
干预措施: Duloxetine (Drug)
Acupressure followed by Duloxetine
干预措施: Duloxetine (Drug)
Duloxetine then add Physical Therapy & Exercise
干预措施: Duloxetine (Drug)
PRISM-CBT followed by Duloxetine
干预措施: Duloxetine (Drug)
Duloxetine followed by Acupressure
干预措施: Duloxetine (Drug)
PRISM-CBT then add Duloxetine
干预措施: Duloxetine (Drug)
Acupressure then add Duloxetine
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change in Pain, Enjoyment and General Activity (PEG) scores
时间窗: T2 (approximately week 6) - T3 (approximately week 15)
The PEG is a three-item survey measure used to assess pain by asking for ratings of Pain intensity, Enjoyment of life, and General activity on a scale of 0-10 over the past week. The final score is the average of the three ratings, with higher scores indicating greater pain severity or interference.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores(T2 (approximately week 6) - T3 (approximately week 15))
- Patient Global Impression of Pain (PGIC)(T3 (approximately week 15))
- Change in ecological momentary assessment (EMA)-derived mean Pain Interference(T2 (approximately week 6) - T3 (approximately week 15))
- Change in Oswestry Disability Index (ODI) scores(T2 (approximately week 6) - T3 (approximately week 15))
研究者
Afton Hassett, Psy.D.
Associate Professor of Anesthesiology, Associate Professor of Internal Medicine and Program Director, Anesthesiology
University of Michigan