Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT)
11 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
500
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Sana Shaikh
- Numer telefonu: 734-763-5226
- E-mail: skazi@med.umich.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Beth Banner
- Numer telefonu: 734-763-5226
- E-mail: eledward@med.umich.edu
Lokalizacje studiów
-
-
Michigan
-
Ann Arbor, Michigan, Stany Zjednoczone, 48109
- Rekrutacyjny
- University of Michigan
-
Kontakt:
- Sana Shaikh
- Numer telefonu: 734-763-5226
- E-mail: skazi@med.umich.edu
-
Główny śledczy:
- Daniel Clauw, MD
-
Główny śledczy:
- Afton Hassett, PsyD
-
Kontakt:
- Beth Banner
- Numer telefonu: 734-763-5226
- E-mail: eledward@med.umich.edu
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Pain, Enjoyment and General Activity (PEG) scores
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Afton Hassett, PsyD, University of Michigan
- Główny śledczy: Daniel Clauw, MD, University of Michigan
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
23 lipca 2026
Zakończenie podstawowe (Szacowany)
1 lutego 2030
Ukończenie studiów (Szacowany)
1 lipca 2030
Daty rejestracji na studia
Pierwszy przesłany
22 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 lipca 2026
Pierwszy wysłany (Rzeczywisty)
28 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 września 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Związki siarki
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Lecznictwo
- Terapia behawioralna
- Psychoterapia
- Dyscypliny i działania behawioralne
- Rehabilitacja
- Tiofeny
- Chlorowodorek duloksetyny
- Ćwiczenia
- Terapia behawioralna poznawcza
- Fizjoterapia
Inne numery identyfikacyjne badania
- HUM00273626
- UC2AR086182 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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).
Ramy czasowe udostępniania IPD
The data will be made available when the study is completed and available as long as the NIH deems appropriate.
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .