Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT)
11. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
500
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Sana Shaikh
- Telefonnummer: 734-763-5226
- E-Mail: skazi@med.umich.edu
Studieren Sie die Kontaktsicherung
- Name: Beth Banner
- Telefonnummer: 734-763-5226
- E-Mail: eledward@med.umich.edu
Studienorte
-
-
Michigan
-
Ann Arbor, Michigan, Vereinigte Staaten, 48109
- Rekrutierung
- University of Michigan
-
Kontakt:
- Sana Shaikh
- Telefonnummer: 734-763-5226
- E-Mail: skazi@med.umich.edu
-
Hauptermittler:
- Daniel Clauw, MD
-
Hauptermittler:
- Afton Hassett, PsyD
-
Kontakt:
- Beth Banner
- Telefonnummer: 734-763-5226
- E-Mail: eledward@med.umich.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Pain, Enjoyment and General Activity (PEG) scores
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Afton Hassett, PsyD, University of Michigan
- Hauptermittler: Daniel Clauw, MD, University of Michigan
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. Juli 2026
Primärer Abschluss (Geschätzt)
1. Februar 2030
Studienabschluss (Geschätzt)
1. Juli 2030
Studienanmeldedaten
Zuerst eingereicht
22. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Juli 2026
Zuerst gepostet (Tatsächlich)
28. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. September 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Schwefelverbindungen
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Therapeutika
- Verhaltenstherapie
- Psychotherapie
- Verhaltensdisziplinen und Aktivitäten
- Rehabilitation
- Thiophenes
- Duloxetinhydrochlorid
- Übung
- Kognitive Verhaltenstherapie
- Physiotherapiemodalitäten
Andere Studien-ID-Nummern
- HUM00273626
- UC2AR086182 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
The data will be made available when the study is completed and available as long as the NIH deems appropriate.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .