[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731750":3,"trial-entities:NCT07731750":164,"trial-summary:NCT07731750":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":79,"secondary_outcomes":84,"sex":98,"minimum_age":99,"maximum_age":14,"healthy_volunteers":100,"eligibility_criteria":101,"std_ages":130,"locations":133,"central_contacts":156,"overall_officials":159,"references":162,"see_also_links":163},"NCT07731750","HUM00273626","Algorithm-informed Decision-making to Advance Pain Treatment","Algorithm-informed Decision-making to Advance Pain Treatment (ADAPT Study)","NOT_YET_RECRUITING","2030-07","2026-07","2026-07-28","University of Michigan","OTHER",null,"Researchers are exploring how certain personal factors, such as symptoms, health history, and lifestyle, may help predict which treatments will work best for someone.\n\nThe 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.","During the treatment stages participants may be placed into the following interventions:\n\n1. Physical Therapy \\& Exercise -10, standardized sessions over 8 weeks delivered individually and in-person by a physical therapist\n2. Duloxetine - FDA approved for musculoskeletal pain, self-administered SNRI medication taken daily over 8 weeks.\n3. Acupressure- a mobile health program- self-administered mHealth program with daily practice over 8 weeks.\n4. PRISM- cognitive-behavioral therapy plus resilience training- 8, weekly, digitally delivered pain self-management modules with corresponding weekly 15-minute standardized telehealth coaching sessions.\n\nAfter 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).\n\nAnalysis 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.",[18],"Chronic Low-back Pain",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[23],"NA",{"count":25,"type":26},500,"ESTIMATED",[28,61,66,70,74],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Algorithmically informed randomization (taking into account phenotypes)","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.",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60],"Acupressure followed by Duloxetine","Acupressure followed by PRISM-CBT","Acupressure followed by Physical Therapy & Exercise","Acupressure then add Duloxetine","Acupressure then add PRISM-CBT","Acupressure then add Physical Therapy & Exercise","Acupressure then continue","Duloxetine and Continue","Duloxetine followed by Acupressure","Duloxetine followed by PRISM-CBT","Duloxetine followed by Physical Therapy & Exercise","Duloxetine then add Acupressure","Duloxetine then add PRISM-CBT","Duloxetine then add Physical Therapy & Exercise","PRISM-CBT and continue","PRISM-CBT followed by Acupressure","PRISM-CBT followed by Duloxetine","PRISM-CBT followed by Physical Therapy & Exercise","PRISM-CBT then add Acupressure","PRISM-CBT then add Duloxetine","PRISM-CBT then add Physical Therapy & Exercise","Physical Therapy & Exercise and continue","Physical Therapy & Exercise followed by Acupressure","Physical Therapy & Exercise followed by Duloxetine","Physical Therapy & Exercise followed by PRISM-CBT","Physical Therapy & Exercise then add Acupressure","Physical Therapy & Exercise then add Duloxetine","Physical Therapy & Exercise then add PRISM-CBT",{"type":62,"name":63,"description":64,"armGroupLabels":65},"BEHAVIORAL","Physical Therapy (PT) and Exercise","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.",[35,38,46,50,53,54,55,56,57,58,59,60],{"type":62,"name":67,"description":68,"armGroupLabels":69},"Cognitive-Behavioral Therapy for Pain (PRISM-CBT)","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.",[34,37,42,45,47,48,49,50,51,52,53],{"type":62,"name":71,"description":72,"armGroupLabels":73},"mHealth Acupressure Self-Management:","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.",[33,34,35,36,37,38,39,44,48,51],{"type":75,"name":76,"description":77,"armGroupLabels":78},"DRUG","Duloxetine","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.",[33,36,40,41,42,43,44,45,46,49,52,56,59],[80],{"measure":81,"description":82,"timeFrame":83},"Change in Pain, Enjoyment and General Activity (PEG) scores","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)",[85,88,92,95],{"measure":86,"description":87,"timeFrame":83},"Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores","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.",{"measure":89,"description":90,"timeFrame":91},"Patient Global Impression of Pain (PGIC)","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)",{"measure":93,"description":94,"timeFrame":83},"Change in ecological momentary assessment (EMA)-derived mean Pain Interference","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.\"",{"measure":96,"description":97,"timeFrame":83},"Change in Oswestry Disability Index (ODI) scores","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","ALL","25 Years",false,{"inclusion":102,"exclusion":107,"raw_text":129},[103,104,105,106],"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",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128],"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\u002Falcohol 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\u002Fplanned (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","Inclusion Criteria:\n\n* 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\n* 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.\n* Individuals must be willing and eligible to receive at least three of the four proposed interventions.\n* Able to stand for at least 10 minutes\n\nExclusion Criteria:\n\n* 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.\n* Unable to read, write of speak fluent English\n* Visual or hearing difficulties that would preclude participation\n* Active uncontrolled drug\u002Falcohol addiction\n* Individuals receiving new disability or compensation or involved in litigation in the past 12 months.\n* Pregnancy or breastfeeding\n* Individuals on high doses of opioids (over 100 Oral Morphine Equivalents \\[OME\\] per day).\n* Upcoming scheduled back surgery, back surgery within the last year, or more than one back surgery in the past.\n* History of discitis osteomyelitis (spine infection) or spine tumor\n* History of an autoimmune disorder such as ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus\n* History of cauda equina syndrome or spinal radiculopathy\n* Diagnosis of schizophrenia or schizoaffective diagnosis\n* Diagnosis of any vertebral fracture in the last 6 months\n* Osteoporosis requiring treatment (vitamin D and calcium supplements are acceptable)\n* Cancer\n\n  * History of any bone-related cancer or cancer that metastasized to the bone\n  * Currently in treatment for cancer or plan to start cancer treatment in the next 12 months\n  * History of any cancer treatment in the last 24 months\n* Life expectancy is less than 2 years\n* Current\u002Fplanned (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.\n* 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",[131,132],"ADULT","OLDER_ADULT",[134],{"facility":12,"city":135,"state":136,"zip":137,"country":138,"contacts":139,"geoPoint":153},"Ann Arbor","Michigan","48109","United States",[140,145,148,151],{"name":141,"role":142,"phone":143,"email":144},"Beth Banner","CONTACT","734-763-5226","eledward@med.umich.edu",{"name":146,"role":142,"phone":143,"email":147},"Sana Shaikh","skazi@med.umich.edu",{"name":149,"role":150},"Afton Hassett, PsyD","PRINCIPAL_INVESTIGATOR",{"name":152,"role":150},"Daniel Clauw, MD",{"lat":154,"lon":155},42.27756,-83.74088,[157,158],{"name":141,"role":142,"phone":143,"email":144},{"name":146,"role":142,"phone":143,"email":147},[160,161],{"name":149,"affiliation":12,"role":150},{"name":152,"affiliation":12,"role":150},[],[],{"nct_id":4,"conditions":165,"biomarkers":167},[166],"Chronic low back pain",[],{"nct_id":4,"found":169,"summary":170,"prompt_version":180},true,{"design":171,"status":172,"heading":173,"summary":174,"follow_up":175,"word_count":176,"commitments":177,"compensation":178,"drugs_mentioned":179},"This is an interventional study involving 500 participants. An algorithm will help decide which treatment you receive, based on your personal health information.","completed","Algorithm-informed Decision-making for Chronic Low-back Pain Treatment","This study is looking for 500 participants with chronic low-back pain (pain lasting at least six months) to see if a special computer program (algorithm) can help choose the best treatment for each person. Researchers want to understand how your unique health information, like symptoms and medical history, can predict which treatments will work best for you. You might receive Physical Therapy and Exercise, Cognitive-Behavioral Therapy for Pain (PRISM-CBT), mHealth Acupressure Self-Management, or Duloxetine (an FDA-approved medication for chronic pain). The main goal is to see how much your pain, enjoyment of life, and daily activities improve after about 6 to 15 weeks of treatment.","Your pain, enjoyment, and general activity will be measured after about 6 weeks and again at about 15 weeks.",105,"You would receive one of four interventions: 10 in-person physical therapy sessions over 8 weeks, daily Duloxetine medication for 8 weeks, daily self-acupressure for 8 weeks, or 8 weekly virtual CBT sessions with coaching.","Not stated in the trial record.",[67,76],"v2"]