{"protocolSection":{"identificationModule":{"nctId":"NCT05396014","orgStudyIdInfo":{"id":"21-1972"},"secondaryIdInfos":[{"id":"1U24AR076730","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1U24AR076730"}],"organization":{"fullName":"University of North Carolina, Chapel Hill","class":"OTHER"},"briefTitle":"The BEST Trial: Biomarkers for Evaluating Spine Treatments","officialTitle":"The BEST Trial: Biomarkers for Evaluating Spine Treatments","acronym":"BEST"},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-09-12","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-07-30","type":"ACTUAL"},"completionDateStruct":{"date":"2024-10-22","type":"ACTUAL"},"studyFirstSubmitDate":"2022-05-24","studyFirstSubmitQcDate":"2022-05-24","studyFirstPostDateStruct":{"date":"2022-05-27","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-05-30","resultsFirstSubmitQcDate":"2025-07-02","resultsFirstPostDateStruct":{"date":"2025-07-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-07-02","lastUpdatePostDateStruct":{"date":"2025-07-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of North Carolina, Chapel Hill","class":"OTHER"},"collaborators":[{"name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)-sponsored clinical trial being conducted through the NIH Helping to End Addiction Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating the optimal treatment or combination of treatments based on patient features and response to the initial treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.","detailedDescription":"Each participant will complete an initial screening call and enrollment visit, followed by a 2-week run-in period, two consecutive 12-week treatment periods, and a 12-week post-treatment follow-up period. Upon completion of the run-in period, participant eligibility will be reassessed based on adherence to study protocol. Participants who no longer meet eligibility criteria will be considered screen failures and discontinued from the study.\n\nAll participants will undergo phenotyping assessments at Visit 0, 1 and 2 corresponding to baseline, the end of the first 12-week intervention period, and the end of the second 12-week intervention period, respectively. A subset of participants will undergo additional phenotyping, consisting of a more comprehensive set of phenotyping assessments, at the same visits.\n\nPain, Enjoyment of Life, and General Activity (PEG) and Patient Global Impressions Scale (PGIC) will be assessed at 6 weeks (midpoint of intervention period one), 12 weeks (Visit 1), 18 weeks (midpoint of intervention period two), 24 weeks (Visit 2), and 36 weeks post-baseline (12 weeks after intervention period two). Basic safety assessments will also be performed at these time points to assess participant tolerability to their current study intervention(s). Patients who are unable to tolerate their assigned study treatment will be educated on how to safely discontinue their current treatment plan but will otherwise remain in the study."},"conditionsModule":{"conditions":["Chronic Low-back Pain"],"keywords":["Pain","Back Pain"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","interventionModelDescription":"Sequential Multiple Assignment Randomized Trial (SMART)","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1014,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Treatment Period 1: Enhanced Self-Care (ESC)","type":"ACTIVE_COMPARATOR","description":"This arm includes participants who are randomized to ESC in Treatment Period 1.\n\nDepending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ESC or be randomized to augment ESC with an additional treatment during Treatment Period 2.","interventionNames":["Behavioral: Enhanced Self-Care (ESC)"]},{"label":"Treatment Period 1: Acceptance and Commitment Therapy (ACT)","type":"ACTIVE_COMPARATOR","description":"This arm includes participants who are randomized to ACT in Treatment Period 1.\n\nDepending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ACT, augment ACT with an additional treatment, or switch to a new treatment during Treatment Period 2.","interventionNames":["Behavioral: Acceptance and Commitment Therapy (ACT)"]},{"label":"Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)","type":"ACTIVE_COMPARATOR","description":"This arm includes participants who are randomized to EBEM in Treatment Period 1.\n\nDepending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on EBEM, augment EBEM with an additional treatment, or switch to a new treatment during Treatment Period 2.","interventionNames":["Behavioral: Evidence-Based Exercise and Manual Therapy (EBEM)"]},{"label":"Treatment Period 1: Duloxetine","type":"ACTIVE_COMPARATOR","description":"This arm includes participants who are randomized to Duloxetine in Treatment Period 1.\n\nDepending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on Duloxetine, augment Duloxetine with an additional treatment, or switch to a new treatment during Treatment Period 2.","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"BEHAVIORAL","name":"Enhanced Self-Care (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.","armGroupLabels":["Treatment Period 1: Enhanced Self-Care (ESC)"]},{"type":"BEHAVIORAL","name":"Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.","armGroupLabels":["Treatment Period 1: Acceptance and Commitment Therapy (ACT)"]},{"type":"BEHAVIORAL","name":"Evidence-Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.","armGroupLabels":["Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)"]},{"type":"DRUG","name":"Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.","armGroupLabels":["Treatment Period 1: Duloxetine"],"otherNames":["Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Patient-Reported Pain Intensity and Interference Score","description":"Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.","timeFrame":"Baseline, 24 Weeks"}],"secondaryOutcomes":[{"measure":"Patient-Reported Outcomes Measurement Information System-Pain Interference","description":"Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions, and measures self-reported consequences of pain on relevant aspects of one's life. Results range from -34 to 34 (t-scores range from 41.6 to 75.6). For each t-score, 50 indicates the population mean with a standard deviation of 10. Lower scores indicate lower pain interference and a better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Number of Participants Self-Reporting Taking Opioids","description":"The number of participants self-reporting taking opioids (\"Yes\" response) is measured by a single question, \"Are you currently taking any opioid pain medication on a daily basis?\".","timeFrame":"24 Weeks"},{"measure":"Patient-Reported Outcomes Measurement Information System- Physical Function","description":"Physical function is measured by the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. T-scores range from 21.6 to 58.7 and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -37.1 to 37.1, with higher physical function scores indicating a better outcome and increased physical functioning at 24 Weeks compared to Baseline. A higher physical function is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score","description":"Depression score is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. T-scores range from 41.0 to 79.4), and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -38.4 to 38.4, with higher scores indicating increased depression at 24 Weeks compared to Baseline. A lower depression score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety","description":"Anxiety score is measured by the Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety (PROMIS-EDA) scale 4a. The PROMIS-EDA 4a is a series of 4 questions. T-scores range from 40.3 to 81.6, and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -41.3 to 41.3, with higher scores indicating increased anxiety at 24 Weeks compared to Baseline. A lower anxiety score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Patient-Reported Outcomes Measurement Information System - Sleep Disturbance","description":"Sleep disturbance is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form 6a. The PROMIS short form 6a is a series of 6 questions. T-scores range from 31.7 to 76.1 and for each t-score, 50 indicates the population mean with a standard deviation of 10). Results range from -44.4 to 44.4, with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline. A lower sleep disturbance score is the better outcome. PPROMIS measures are not used for clinical decision making but to describe participant symptoms.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Sleep Duration","description":"Sleep duration is measured by the Back Pain Consortium (BACPAC) sleep duration question, \"During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed).\" Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.","timeFrame":"Baseline, 24 Weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nTo be eligible, an individual must meet all of the following inclusion criteria:\n\n* Ability to read and understand English\n* Provision of signed and dated informed consent form(s)\n* Willing and able to receive study-related messages and survey links via email\n* Willing and able to receive study-related phone calls\n* Age 18 years old or older\n* Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months\n* Contraindicated to no more than one of the study interventions at the time of eligibility assessment(s)\n* Eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible\n* A PEG score 4 or higher prior to the Run-in period\n* Willing and able to undergo required phenotyping\n* Regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer\n* Meet Run-in period engagement eligibility criteria:\n\n  o Completion of two Run-in study information modules prior to period 1 randomization (Visit 0)\n* Low-back pain more severe than pain in other parts of the body\n* Available to complete the full study protocol (approximately 9 months)\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant at the time of Visit 0 (Baseline)\n* Affirmative participant response to any of the following conditions:\n\n  * Progressive neurodegenerative disease\n  * History of discitis osteomyelitis (spine infection) or spine tumor\n  * History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus\n  * History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength \\<4/5 on manual motor testing)\n  * Diagnosis of any vertebral fracture in the last 6 months\n  * Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates.\n  * History of any bone-related cancer or cancer that metastasized to the bone\n  * Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months\n  * History of any non-skin cancer treatment in the last 24 months\n  * Visual or hearing difficulties that would preclude participation\n  * Uncontrolled drug/alcohol addiction\n  * Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation\n  * Currently participating in another interventional pain study\n* Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Kevin Anstrom, PhD","affiliation":"UNC Chapel Hill","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Matthew Mauck, PhD","affiliation":"UNC Chapel Hill","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Gwendolyn Sowa, PhD","affiliation":"University of Pittsburgh","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Daniel Clauw, MD","affiliation":"University of Michigan","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Stanford University","city":"Redwood City","state":"California","zip":"94063","country":"United States","geoPoint":{"lat":37.48522,"lon":-122.23635}},{"facility":"University of California, San Diego","city":"San Diego","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","zip":"94158","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"University of Kansas Health System","city":"Kansas City","state":"Kansas","zip":"66160","country":"United States","geoPoint":{"lat":39.11417,"lon":-94.62746}},{"facility":"Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical School","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","zip":"48189","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"facility":"University of North Carolina Hospital Pain Management Clinic","city":"Chapel Hill","state":"North Carolina","zip":"27599","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"Atrium Health Wake Forest Baptist","city":"Winston-Salem","state":"North Carolina","zip":"27517","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"The Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","zip":"43203","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","zip":"15219","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"University of Washington","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"40794568","type":"DERIVED","citation":"Rowland B, Barth KS, Bell KM, Brooks AK, Chadwick AL, Cleven A, Hurley RW, Mackey S, Patel KV, Piva SR, Schneider MJ, Al-Kadhi F, Asante-Nketiah B, Bagaason S, Batorsky A, Borckardt JJ, Bowden AE, Carey TS, Castellanos J, Chen L, Chidgey B, Dalton D, Dufour JS, Eberting JL, Eller SM, Fields AJ, Fritz JM, Fu A, Ghulamhussain I, Goolsby RW, Greco CM, Grim S, Gunn CA, Hanes L, Harris RE, Harte SE, Hassett AL, Helton K, Hoffmeyer A, Ivanova A, Jones Berkeley S, Kaplan C, Kidwell KM, Knapik GG, Kosorok MR, Kurillo G, Li D, Lobo R, Long J, Lotz JC, Mageswaran P, Majumdar S, Mao J, Marras WS, McCracken LM, McCumber M, McLean SA, McMillan M, Mehling W, Mendoza R, Mitchell UH, Napadow V, O'Neill C, Pearson S, Peltier S, Rundell SD, Ryser S, Schrepf A, Schulze E, Sperger J, Vo N, Wallace MS, Wampler AM, Wasan AD, Weaver TE, Weber KA 2nd, Wilcox L, Williams DA, Wilson L, Woo JE, Zeidan F, Zhao B, Zhou B, Anstrom KJ, Clauw DJ, Sowa GA, Mauck MC. Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back paindagger. Pain Med. 2025 Nov 1;26(11):758-772. doi: 10.1093/pm/pnaf073."},{"pmid":"40249098","type":"DERIVED","citation":"Jones Berkeley S, Wedin S, Patidar SM, Margolies SO, Goetzinger AM, Mauck MC, Wasan AD, McCracken LM. Design and implementation of online acceptance and commitment therapy with enhanced therapist support for chronic low back pain (ACT for PAIN). Pain Med. 2025 Aug 1;26(8):451-458. doi: 10.1093/pm/pnaf026."},{"pmid":"40205455","type":"DERIVED","citation":"Mauck MC, Barth KS, Bell KM, Brooks AK, Chadwick AL, Gunn CA, Hurley RW, Ivanova A, Piva SR, Schneider MJ, Bailey JF, Bagaason S, Batorsky A, Borckardt JJ, Bowden AE, Carey TS, Castellanos J, Chen L, Chidgey B, Dalton D, Dufour JS, Fields AJ, Fritz JM, Goolsby RW, Greco CM, Harris RE, Harte S, Hassett AL, Hoffmeyer A, Jones Berkeley S, Kaplan C, Kidwell KM, Knapik GG, Kosorok MR, Kurillo G, Lobo R, Lotz JC, Mackey S, Mageswaran P, Majumdar S, Mao J, Marras WS, McCumber M, McLean SA, Mehling W, Mitchell UH, Napadow VJ, O'Neill C, Patel KV, Peltier S, Psioda M, Rowland B, Rundell SD, Schrepf A, Sperger J, Vo N, Wallace MS, Wasan AD, Weaver TE, Weber KA 2nd, Williams DA, Wilson L, Zeidan F, Zhao B, Anstrom KJ, Clauw DJ, Sowa GA. The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial. Pain Med. 2025 Sep 1;26(9):538-553. doi: 10.1093/pm/pnaf032."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"All relevant study data will be shared through NIH portals as required.","timeFrame":"Data will be made publicly available on the NIH HEAL Platform or other NIH repositories after acceptance of publication for the primary results per NIH HEAL Data Sharing Policy and will remain available for a minimum of 10 years.","accessCriteria":"BACPAC Data Access and Publications Policy:\n\nhttps://sites.cscc.unc.edu/cscc/sites/default/files/bacpac/qxq/BACPAC\\_Data\\_Access\\_and\\_Publications\\_Policy.pdf\n\nData from this study may be requested by other researchers by using the HEAL Data Platform: https://heal.nih.gov/data/heal-data-ecosystem","url":"https://heal.nih.gov/data/public-access-data"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"While 1014 participants in total were enrolled in the trial, 805 were randomized. This was due to participant withdrawal or participant ineligibility during the run-in period between the enrollment visit and randomization.","groups":[{"id":"FG000","title":"Acceptance and Commitment Therapy (ACT) Alone","description":"This arm included both participants who had a strong response to Acceptance and Commitment Therapy (ACT) in Period 1 and participants who were not assessed for response at the end of Period 1. In Period 1, participants randomized to ACT took part in 12 therapy sessions over the course of 12 weeks. Each participant was scheduled for a combination of 4 remote face-to-face visits and 8 therapist-supported online sessions, which included a self-directed module combined with personalized provider coaching delivered via an online messaging system. In Period 2, strong responders were encouraged to continue to practice ACT skills at home without therapist supervision and were given access to an additional 11 ACT audio modules."},{"id":"FG001","title":"ACT Plus Duloxetine, Moderate Treatment Response","description":"This arm included participants who had a moderate response to ACT in Period 1 and started Duloxetine in Period 2 while continuing ACT treatment."},{"id":"FG002","title":"ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to ACT in Period 1 and started Evidence Based Exercise and Manual Therapy (EBEM) treatment in Period 2 while continuing ACT."},{"id":"FG003","title":"ACT Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to ACT in Period 1 and started Enhanced Self-Care Therapy (ESC) treatment in Period 2 while continuing ACT."},{"id":"FG004","title":"ACT Plus Duloxetine, Low Period 1 Treatment Response","description":"This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2 while continuing ACT."},{"id":"FG005","title":"ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2 while continuing ACT."},{"id":"FG006","title":"ACT Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2 while continuing ACT."},{"id":"FG007","title":"ACT Followed by Duloxetine, Low Period 1 Treatment Response","description":"This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued."},{"id":"FG008","title":"ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued."},{"id":"FG009","title":"ACT Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued."},{"id":"FG010","title":"ACT Followed by Duloxetine, Poor Period 1 Treatment Response","description":"This arm included participants who had a poor response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued."},{"id":"FG011","title":"ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Treatment Response","description":"This arm included participants who had a poor response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued."},{"id":"FG012","title":"ACT Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response","description":"This arm included participants who had a poor response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued."},{"id":"FG013","title":"Duloxetine Alone","description":"This arm included both participants who had a strong response to Duloxetine in Period 1 and participants who were not assessed for response at the end of Period 1."},{"id":"FG014","title":"Duloxetine Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine."},{"id":"FG015","title":"Duloxetine Plus Evidence Based Exercise & Manual Therapy(EBEM), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine."},{"id":"FG016","title":"Duloxetine Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine."},{"id":"FG017","title":"Duloxetine Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine."},{"id":"FG018","title":"Duloxetine Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine."},{"id":"FG019","title":"Duloxetine Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine."},{"id":"FG020","title":"Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued."},{"id":"FG021","title":"Duloxetine Followed by Evidence Based Exercise and Manual Therapy(EBEM), Low Period 1 Trt Response","description":"This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued."},{"id":"FG022","title":"Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued."},{"id":"FG023","title":"Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response","description":"This arm included participants who had a poor response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued."},{"id":"FG024","title":"Duloxetine Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Trt Response","description":"This arm included participants who had a poor response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued."},{"id":"FG025","title":"Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response","description":"This arm included participants who had a poor response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued."},{"id":"FG026","title":"Evidence Based Exercise and Manual Therapy (EBEM) Alone","description":"This arm included both participants who had a strong response to EBEM in Period 1 and participants who were not assessed for response at the end of Period 1."},{"id":"FG027","title":"EBEM Plus Duloxetine, Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM."},{"id":"FG028","title":"EBEM Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM."},{"id":"FG029","title":"EBEM Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response","description":"This arm included participants who had a moderate response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM."},{"id":"FG030","title":"EBEM Plus Duloxetine, Low Period 1 Treatment Response","description":"This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM."},{"id":"FG031","title":"EBEM Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM."},{"id":"FG032","title":"EBEM Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response","description":"This arm included participants who had a low response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM."},{"id":"FG033","title":"EBEM Followed by Duloxetine, Low Period 1 Treatment Response","description":"This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2. 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A higher score indicates more likely depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"203"},{"groupId":"BG001","value":"198"},{"groupId":"BG002","value":"199"},{"groupId":"BG003","value":"205"},{"groupId":"BG004","value":"805"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"1.6","spread":"1.6"},{"groupId":"BG001","value":"1.2","spread":"1.2"},{"groupId":"BG002","value":"1.4","spread":"1.6"},{"groupId":"BG003","value":"1.6","spread":"1.6"},{"groupId":"BG004","value":"1.5","spread":"1.5"}]}]}]},{"title":"Healing Encounters and Attitudes Lists (HEAL) Positive Outlook: Raw Score","description":"HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. HEAL measures patient-reported aspects of healing encounters and attitudes. 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Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.16","lowerLimit":"3.74","upperLimit":"4.58"},{"groupId":"OG001","value":"3.86","lowerLimit":"3.43","upperLimit":"4.28"},{"groupId":"OG002","value":"3.57","lowerLimit":"3.15","upperLimit":"3.99"},{"groupId":"OG003","value":"4.72","lowerLimit":"4.3","upperLimit":"5.14"}]}]}]},{"type":"SECONDARY","title":"Patient-Reported Outcomes Measurement Information System-Pain Interference","description":"Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions, and measures self-reported consequences of pain on relevant aspects of one's life. Results range from -34 to 34 (t-scores range from 41.6 to 75.6). For each t-score, 50 indicates the population mean with a standard deviation of 10. Lower scores indicate lower pain interference and a better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"t-scores","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"59.03","lowerLimit":"57.67","upperLimit":"60.39"},{"groupId":"OG001","value":"58.48","lowerLimit":"57.12","upperLimit":"59.84"},{"groupId":"OG002","value":"57.61","lowerLimit":"56.25","upperLimit":"58.97"},{"groupId":"OG003","value":"60.13","lowerLimit":"58.77","upperLimit":"61.49"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Self-Reporting Taking Opioids","description":"The number of participants self-reporting taking opioids (\"Yes\" response) is measured by a single question, \"Are you currently taking any opioid pain medication on a daily basis?\".","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"}]}]}]},{"type":"SECONDARY","title":"Patient-Reported Outcomes Measurement Information System- Physical Function","description":"Physical function is measured by the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. T-scores range from 21.6 to 58.7 and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -37.1 to 37.1, with higher physical function scores indicating a better outcome and increased physical functioning at 24 Weeks compared to Baseline. A higher physical function is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"t-scores","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.14","lowerLimit":"40.81","upperLimit":"43.46"},{"groupId":"OG001","value":"43.32","lowerLimit":"41.99","upperLimit":"44.64"},{"groupId":"OG002","value":"43.11","lowerLimit":"41.78","upperLimit":"44.43"},{"groupId":"OG003","value":"41.18","lowerLimit":"39.86","upperLimit":"42.5"}]}]}]},{"type":"SECONDARY","title":"Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score","description":"Depression score is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. T-scores range from 41.0 to 79.4), and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -38.4 to 38.4, with higher scores indicating increased depression at 24 Weeks compared to Baseline. A lower depression score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"t-scores","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49.22","lowerLimit":"47.71","upperLimit":"50.74"},{"groupId":"OG001","value":"47.83","lowerLimit":"46.32","upperLimit":"49.35"},{"groupId":"OG002","value":"49.03","lowerLimit":"47.51","upperLimit":"50.54"},{"groupId":"OG003","value":"50.19","lowerLimit":"48.68","upperLimit":"51.71"}]}]}]},{"type":"SECONDARY","title":"Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety","description":"Anxiety score is measured by the Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety (PROMIS-EDA) scale 4a. The PROMIS-EDA 4a is a series of 4 questions. T-scores range from 40.3 to 81.6, and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -41.3 to 41.3, with higher scores indicating increased anxiety at 24 Weeks compared to Baseline. A lower anxiety score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"t-scores","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49.73","lowerLimit":"48.1","upperLimit":"51.35"},{"groupId":"OG001","value":"48.15","lowerLimit":"46.52","upperLimit":"49.77"},{"groupId":"OG002","value":"49.14","lowerLimit":"47.52","upperLimit":"50.77"},{"groupId":"OG003","value":"50.43","lowerLimit":"48.8","upperLimit":"52.05"}]}]}]},{"type":"SECONDARY","title":"Patient-Reported Outcomes Measurement Information System - Sleep Disturbance","description":"Sleep disturbance is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form 6a. The PROMIS short form 6a is a series of 6 questions. T-scores range from 31.7 to 76.1 and for each t-score, 50 indicates the population mean with a standard deviation of 10). Results range from -44.4 to 44.4, with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline. A lower sleep disturbance score is the better outcome. PPROMIS measures are not used for clinical decision making but to describe participant symptoms.","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"t-scores","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.61","lowerLimit":"50.98","upperLimit":"54.25"},{"groupId":"OG001","value":"51.45","lowerLimit":"49.82","upperLimit":"53.09"},{"groupId":"OG002","value":"51.91","lowerLimit":"50.28","upperLimit":"53.54"},{"groupId":"OG003","value":"53.21","lowerLimit":"51.58","upperLimit":"54.84"}]}]}]},{"type":"SECONDARY","title":"Sleep Duration","description":"Sleep duration is measured by the Back Pain Consortium (BACPAC) sleep duration question, \"During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed).\" Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.","populationDescription":"The analysis population is the all-randomized population to Stage 1 interventions.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 24 Weeks","groups":[{"id":"OG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered."},{"id":"OG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed."},{"id":"OG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each."},{"id":"OG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"205"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.82","lowerLimit":"6.58","upperLimit":"7.06"},{"groupId":"OG001","value":"6.74","lowerLimit":"6.49","upperLimit":"6.98"},{"groupId":"OG002","value":"6.73","lowerLimit":"6.49","upperLimit":"6.97"},{"groupId":"OG003","value":"6.67","lowerLimit":"6.43","upperLimit":"6.91"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.","eventGroups":[{"id":"EG000","title":"Stage 1: Acceptance and Commitment Therapy (ACT)","description":"ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.","deathsNumAffected":0,"deathsNumAtRisk":191,"seriousNumAffected":4,"seriousNumAtRisk":191,"otherNumAffected":2,"otherNumAtRisk":191},{"id":"EG001","title":"Stage 1: Duloxetine","description":"Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.","deathsNumAffected":0,"deathsNumAtRisk":172,"seriousNumAffected":1,"seriousNumAtRisk":172,"otherNumAffected":92,"otherNumAtRisk":172},{"id":"EG002","title":"Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.","deathsNumAffected":0,"deathsNumAtRisk":184,"seriousNumAffected":6,"seriousNumAtRisk":184,"otherNumAffected":7,"otherNumAtRisk":184},{"id":"EG003","title":"Stage 1: Enhanced Self-Care Therapy (ESC)","description":"The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.","deathsNumAffected":0,"deathsNumAtRisk":205,"seriousNumAffected":2,"seriousNumAtRisk":205,"otherNumAffected":4,"otherNumAtRisk":205},{"id":"EG004","title":"Stage 2: Acceptance and Commitment Therapy (ACT)","description":"Participants newly randomized to ACT in Stage 2 will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Participants assigned to maintain ACT will be encouraged to continue at-home skills and will have access to all previously viewed online content. In addition, participants will have access to 11 additional online ACT audio modules, but without the communications with the therapist.","deathsNumAffected":0,"deathsNumAtRisk":65,"seriousNumAffected":4,"seriousNumAtRisk":65,"otherNumAffected":1,"otherNumAtRisk":65},{"id":"EG005","title":"Stage 2: Duloxetine","description":"Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. All participants will be assessed at the midpoint of the intervention treatment period (Week 18) for tolerance, adverse events, and response. At the midpoint phone call:\n\nParticipants tolerating the medication with no side effects will be instructed to increase to 60mg/day (if currently taking 30mg/day) or remain on their current dosage (if currently taking 60mg/day).","deathsNumAffected":0,"deathsNumAtRisk":71,"seriousNumAffected":0,"seriousNumAtRisk":71,"otherNumAffected":29,"otherNumAtRisk":71},{"id":"EG006","title":"Stage 2: Evidence Based Exercise and Manual Therapy (EBEM)","description":"Participants newly randomized to EBEM in stage 2 will take part in a total of 10 sessions over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each. Participants assigned to maintain EBEM will receive 4 additional in-person EBEM sessions during weeks 1-4 of this period. If visits are missed and/or need to be rescheduled, visits may be scheduled up to 5 weeks from the date of the first augmenting/maintenance visit.","deathsNumAffected":0,"deathsNumAtRisk":110,"seriousNumAffected":3,"seriousNumAtRisk":110,"otherNumAffected":3,"otherNumAtRisk":110},{"id":"EG007","title":"Stage 2: Enhanced Self-Care Therapy (ESC)","description":"Participants newly randomized to ESC in stage 2 will be provided modules digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress. Participants assigned to maintain ESC in the second period intervention will receive personalized recommendations based on the most recently completed PROMIS 29+2.","deathsNumAffected":0,"deathsNumAtRisk":85,"seriousNumAffected":2,"seriousNumAtRisk":85,"otherNumAffected":0,"otherNumAtRisk":85},{"id":"EG008","title":"Stage 2: ACT and Duloxetine","description":"Participants received both ACT and duloxetine in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":1,"seriousNumAtRisk":33,"otherNumAffected":12,"otherNumAtRisk":33},{"id":"EG009","title":"Stage 2: ACT and EBEM","description":"Participants received both ACT and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.","deathsNumAffected":0,"deathsNumAtRisk":52,"seriousNumAffected":0,"seriousNumAtRisk":52,"otherNumAffected":3,"otherNumAtRisk":52},{"id":"EG010","title":"Stage 2: ACT and ESC","description":"Participants received both ACT and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.","deathsNumAffected":0,"deathsNumAtRisk":84,"seriousNumAffected":4,"seriousNumAtRisk":84,"otherNumAffected":2,"otherNumAtRisk":84},{"id":"EG011","title":"Stage 2: Duloxetine and EBEM","description":"Participants received both duloxetine and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":4,"otherNumAtRisk":22},{"id":"EG012","title":"Stage 2: Duloxetine and ESC","description":"Participants received both duloxetine and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.","deathsNumAffected":0,"deathsNumAtRisk":54,"seriousNumAffected":1,"seriousNumAtRisk":54,"otherNumAffected":18,"otherNumAtRisk":54},{"id":"EG013","title":"Stage 2: EBEM and ESC","description":"Participants received both EBEM and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.","deathsNumAffected":0,"deathsNumAtRisk":85,"seriousNumAffected":4,"seriousNumAtRisk":85,"otherNumAffected":5,"otherNumAtRisk":85}],"seriousEvents":[{"term":"Atrial Fibrillation","organSystem":"Cardiac 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