Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT)
2026年9月11日 更新者：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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
500
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sana Shaikh
- 電話番号：734-763-5226
- メール：skazi@med.umich.edu
研究連絡先のバックアップ
- 名前：Beth Banner
- 電話番号：734-763-5226
- メール：eledward@med.umich.edu
研究場所
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- 募集
- University of Michigan
-
コンタクト：
- Sana Shaikh
- 電話番号：734-763-5226
- メール：skazi@med.umich.edu
-
主任研究者：
- Daniel Clauw, MD
-
主任研究者：
- Afton Hassett, PsyD
-
コンタクト：
- Beth Banner
- 電話番号：734-763-5226
- メール：eledward@med.umich.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Pain, Enjoyment and General Activity (PEG) scores
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
時間枠：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)
時間枠：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
時間枠：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
時間枠：T2 (approximately week 6) - T3 (approximately week 15)
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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)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Afton Hassett, PsyD、University of Michigan
- 主任研究者：Daniel Clauw, MD、University of Michigan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月23日
一次修了 (推定)
2030年2月1日
研究の完了 (推定)
2030年7月1日
試験登録日
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
2026年7月22日
最初の投稿 (実際)
2026年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HUM00273626
- UC2AR086182 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
The data will be made available when the study is completed and available as long as the NIH deems appropriate.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。