Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT)
2026년 9월 11일 업데이트: Afton Hassett, Psy.D., University of Michigan
Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)
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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
500
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sana Shaikh
- 전화번호: 734-763-5226
- 이메일: skazi@med.umich.edu
연구 연락처 백업
- 이름: Beth Banner
- 전화번호: 734-763-5226
- 이메일: eledward@med.umich.edu
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan
-
연락하다:
- Sana Shaikh
- 전화번호: 734-763-5226
- 이메일: skazi@med.umich.edu
-
수석 연구원:
- Daniel Clauw, MD
-
수석 연구원:
- Afton Hassett, PsyD
-
연락하다:
- Beth Banner
- 전화번호: 734-763-5226
- 이메일: eledward@med.umich.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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 50. 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
Exclusion Criteria:
- 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)
Cancer
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Physical Therapy & Exercise and continue
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
|
|
실험적: Physical Therapy & Exercise followed by Duloxetine
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
|
|
실험적: Physical Therapy & Exercise followed by PRISM-CBT
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
|
|
실험적: Physical Therapy & Exercise followed by Acupressure
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
|
|
실험적: Physical Therapy & Exercise then add Duloxetine
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
|
|
실험적: Physical Therapy & Exercise then add PRISM-CBT
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
|
|
실험적: Physical Therapy & Exercise then add Acupressure
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
|
|
실험적: Duloxetine and Continue
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
|
|
실험적: Duloxetine followed by Physical Therapy & Exercise
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
|
|
실험적: Duloxetine followed by PRISM-CBT
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: Duloxetine then add Physical Therapy & Exercise
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
|
|
실험적: Duloxetine then add PRISM-CBT
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: Duloxetine then add Acupressure
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: PRISM-CBT and continue
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: PRISM-CBT followed by Physical Therapy & Exercise
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: PRISM-CBT followed by Duloxetine
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: PRISM-CBT followed by Acupressure
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: PRISM-CBT then add Physical Therapy & Exercise
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: PRISM-CBT then add Duloxetine
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
|
|
실험적: PRISM-CBT then add Acupressure
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Acupressure then continue
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Acupressure followed by Duloxetine
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Acupressure followed by PRISM-CBT
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Acupressure then add Physical Therapy & Exercise
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Acupressure then add Duloxetine
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Acupressure then add PRISM-CBT
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A moderate-contact telehealth intervention (8 virtual sessions) integrating standard CBT techniques with positive activity modules to enhance engagement, mood, and self-efficacy.
Weekly modules focus on pacing, cognitive reframing, relaxation, gratitude, and acts of kindness.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
|
실험적: Duloxetine followed by Acupressure
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
This is a serotonin-norepinephrine reuptake inhibitor (SNRI) FDA-approved for chronic pain.
A low-contact pharmacologic intervention consisting of an 8-week dose escalation of 60 mg duloxetine, followed by taper as indicated.
Participants initiate medication at home after a standardized orientation, with remote safety and adherence check-ins.
|
|
실험적: Acupressure followed by Physical Therapy & Exercise
|
After Phenotypic data is collected from participants, the algorithm will use that data to "rank" the likelihood of success of different treatments for an individual; it will then,randomize participants based on two patterns of assignment.
And at visit 3, it will re-randomize those participants who wish to add an additional treatment modality or transfer from one modality to another.
A high-contact intervention (10 in-person sessions) involving individualized programs tailored to participant needs and guided by physical therapy best-practice guidelines.
Treatment emphasizes home exercise, progressive low-intensity conditioning, and functional endurance.
A low-contact, self-guided intervention delivered via the MeTime mobile application, supported by brief staff instruction.
Participants practice daily self-acupressure at ten standardized points for approximately 30 minutes per day, stimulating key acupoints associated with pain modulation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pain, Enjoyment and General Activity (PEG) scores
기간: 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.
|
T2 (approximately week 6) - T3 (approximately week 15)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
기간: T2 (approximately week 6) - T3 (approximately week 15)
|
Interference from pain is assessed using 6 items covering broad functional domains such as life enjoyment, concentration, daily activities, recreation, tasks, and socializing.
The scale uses a recall period of 7 days and a response set ranging from 'Not at all" (1) to "Very much" (5).
Total scores are between 4 and 20, with higher scores indicating increased pain interference.
|
T2 (approximately week 6) - T3 (approximately week 15)
|
|
Patient Global Impression of Pain (PGIC)
기간: T3 (approximately week 15)
|
Overall perceived benefit of treatment will be assessed using the Patient Global Impression of Change (PGIC).34
This single-item question asks "Overall, how do you feel since the beginning of this phase of the study", and participants respond on a 1 - 7 Likert scale where 1 = markedly improved, 2 = somewhat improved, 3 = mildly improved, 4 = the same, and 5 - 7 are correspondingly "worsened".
|
T3 (approximately week 15)
|
|
Change in ecological momentary assessment (EMA)-derived mean Pain Interference
기간: T2 (approximately week 6) - T3 (approximately week 15)
|
Real-time 7-day pain severity measure assessed using Qualtrics.
In practice, participants initiate EMAs at wake, noon and bed-times.
Momentary pain intensity will be assessed with the question: "What is your level of pain right now?" rated on a numerical rating scale from 0 = "no pain" to 10 = "worst pain imaginable."
|
T2 (approximately week 6) - T3 (approximately week 15)
|
|
Change in Oswestry Disability Index (ODI) scores
기간: T2 (approximately week 6) - T3 (approximately week 15)
|
This 10-section scale has good internal consistency, discriminative validity, and sensitivity to change in cLBP.
Respondents check the box next to each statement that describes their pain or disability
|
T2 (approximately week 6) - T3 (approximately week 15)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Afton Hassett, PsyD, University of Michigan
- 수석 연구원: Daniel Clauw, MD, University of Michigan
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 23일
기본 완료 (추정된)
2030년 2월 1일
연구 완료 (추정된)
2030년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 22일
처음 게시됨 (실제)
2026년 7월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HUM00273626
- UC2AR086182 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
After the study is completed, the de-identified, archived data may also be transmitted to and stored in a data repository for use by other researchers including those outside of the study as per the cooperative agreement with the study sponsor, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
IPD 공유 기간
The data will be made available when the study is completed and available as long as the NIH deems appropriate.
IPD 공유 액세스 기준
All researchers/members of the scientific community including those outside of the study. Please contact the study team for additional guidance.
Requesters will sign a Letter of Agreement with the University of Michigan detailing their planned uses of the data and mechanisms by which the data will be kept secure, and access restricted to their study team with appropriate credentials and training in data security. The agreements will also state the recipient will not attempt to identify (or taking steps to identify or re-identify) any individual whose data are included and will not share the data with anyone outside of their research team.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .