The Back Pain Consortium Research Program Study

Study Overview
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Brief Summary
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This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work. This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine). In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study. Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them. The study hypothesizes the following: that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).

Detailed Description
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In addition, the following mechanistic hypothesis and Aims are included: Mindfulness-Based Stress Reduction: Aim 2: the study predicts that patients with chronic low back pain (cLBP) will preferentially respond to this therapy if PROs indicate higher levels of pain catastrophizing, as measured by the Pain Catastrophizing Scale, or lower scores on the Experiences Questionnaire. Aim 3: the study hypothesizes that cLBP patients with decreased activation in response to pain in the subgenual anterior cingulate cortex (sgACC) and Prefrontal Cortex and increased activation in somatosensory cortex (S1) and thalamus will respond preferentially to MBSR. Physical Therapy (PT) and Exercise Aim 2: The primary hypothesis for the light phenotyping protocol is those individuals with the highest scores on the Fear Avoidance Beliefs Questionnaire and lowest scores for PROMIS Self-Efficacy for Managing Symptoms will be most likely to improve from PT/Exercise program. Aim 3: the study hypothesis that low vagal tone and high basal inflammation will predict responsiveness to the PT/Exercise program. Acupressure: Aim 2: The study hypothesizes that females with cLBP will respond better to acupressure than men, as will those with higher scores on the 2011 Fibromyalgia Survey Questionnaire. Aim 3: The study predicts that cLBP patients with higher posterior insula glutamate and/or greater insula - Default Mode Network (DMN) connectivity (as well as increased DMN-S1 connectivity Duloxetine: Aim 2: the study hypothesizes that it will replicate previous studies suggesting that participants with cLBP will preferentially respond to this therapy if patient reported outcomes indicate stronger elements of either neuropathic pain (indicated by a high PainDETECT score) or centralized/nociplastic pain (indicated by more widespread pain on the 2011 Fibromyalgia Survey Questionnaire). Aim 3: the study anticipates then that deficient pain inhibition on quantitative sensory testing, decreased periaqueductal gray (PAG)-insula connectivity, and elevated stimulated inflammatory responses will be associated with a positive response to centrally-acting duloxetine. Additionally, a subset of individuals (n=160) from these groups will be asked to participate in an expanded phenotyping study that will include structural and functional brain neuroimaging, quantitative sensory testing (QST), plasma measures of inflammation, and digital measurement of autonomic tone.

Official Title
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University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: PainGuide
* Behavioral: MBSR
* Behavioral: PT and exercise
* Device: Self -administered acupressure
* Drug: Duloxetine
* Device: Pro-Diary monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Light Phenotyping (all participants): Definition of cLBP described in the NIH Task Force Report on Research Standards for Chronic Low Back Pain (for example (i.e.), low back pain present at least six months, and present more than half of those days. Individuals must have the eligible protocol pain interference score on PROMIS Pain Interference. Individuals must be willing to be randomized to receive any of the four proposed treatments. Exclusion Criteria for Light Phenotyping (all participants): History of discitis osteomyelitis (spine infection) or spine tumor History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing) Diagnosis of any vertebral fracture in the last 6 months Osteoporosis requiring treatment other than vitamin D and calcium supplements Cancer (History of any bone-related cancer or cancer that metastasized to the bone, Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months, History of any cancer treatment in the last 24 months) Life expectancy less than 2 years Unable to speak and write English Visual or hearing difficulties that would preclude participation Presence of any history that would preclude scanning in magnetic resonance imaging (MRI) Uncontrolled drug/alcohol addiction Individuals receiving disability or compensation within the past year, or involved in litigation Pregnancy or breastfeeding History of allergy to duloxetine Individuals on high doses of opioids (over 100 oral morphine equivalents (OME) per day) Scheduled back surgery, back surgery within the last year, or more than one back surgery in the past. Expecting to receive an injection of surgical procedure within the next year for their cLBP Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial. Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction Contraindications to Study Intervention: duloxetine certain medications (per protocol) renal dysfunction (creatinine clearance <30 milliliters per minute (mL/min) or End- Stage Renal Failure) Hepatic dysfunction: Liver function tests (LFTs) elevated times 1.5 Contraindications to Study Intervention: Acupressure Currently receiving acupressure or acupuncture through formal therapy Contraindications to Study Intervention: MBSR Current participation in a structured MBSR program Contraindications to Study Intervention: PT & Exercise Currently receiving any type of structured manual therapy or exercise treatment for low-back pain. Contraindication for manual therapy and/or participation in an exercise program Inclusion Criteria for Deep Phenotyping (subset 160 participants): Right hand dominant (such as the hand used when writing or throwing/catching a ball) Normal visual acuity or correctable (with corrective lenses- glasses or contacts) to at least 20/40 for reading instructions in the MRI and visual sensitivity testing No contraindications to MRI (i.e., metal implants) Willingness to refrain from taking any as needed medications, including pain medications such as Nonsteroidal anti-inflammatory drugs (i.e., Motrin, Advil, Aleve), acetaminophen, and opioids, for 8 hours before undergoing neuroimaging and 10.1 Quantitative Sensory Testing (QST) Willingness to refrain from alcohol and nicotine on the day of QST and neuroimaging (alcohol and nicotine consumption is allowed after testing is completed) Willingness to refrain from any unusual physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable) Able to lie still on back for 2 hours during MRI Exclusion Criteria for Deep Phenotyping (subset 160 participants): Severe claustrophobia precluding MRI and evoked pain testing during scanning Diagnosed peripheral neuropathy Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail) Body Mass Index greater than 45 or unable to comfortably fit in the bore of the MRI magnet

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential, multiple assignment, randomized trial (SMART) design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR (mindfulness-based stress reduction)<br>Run-in treatment then MBSR. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: PT and exercise<br>Run-in treatment then PT and exercise | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Acupressure<br>Run-in treatment then Acupressure | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Duloxetine<br>Run-in treatment then Duloxetine | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: MBSR then PT and exercise<br>Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: MBSR then Acupressure<br>Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: MBSR then Duloxetine<br>Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: PT and exercise then MBSR<br>Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: PT and exercise then Acupressure<br>Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: PT and exercise then Duloxetine<br>Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Acupressure then MBSR<br>Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Acupressure then PT and exercise<br>Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Acupressure then Duloxetine<br>Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Duloxetine then MBSR<br>Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: MBSR<br>* In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Duloxetine then PT and exercise<br>Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Behavioral: PT and exercise<br>* Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: Duloxetine then Acupressure<br>Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>Device: Self -administered acupressure<br>* A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions.<br>Drug: Duloxetine<br>* For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.<br>* Other names: Cymbalta;Device: Pro-Diary monitor<br>* Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36.<br>* Other names: Electronic wrist device that looks like a watch;|
| Experimental: PainGuide<br>Run-in treatment only with no additional treatments. | Behavioral: PainGuide<br>* A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a between week 6 to week 15 | The PROMIS pain interference consists of 4 questions on a Likert scale ranging from 'Not at all (1) to Very much (5), with higher scores indicating increased pain interference. | week 6 (T2), week 15 (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Pain, Enjoyment, and General Activity Scale (PEG) from week 6 to week 15 | This is a 3 question scale where participants select a between 0 (no pain) to 10 (pain is bad and completely interferes). Higher the scores the worse the pain. | week 6 (T2), week 15 (T3) | 
| Change in Patient Global Impression of Change (PGIC) from week 6 to week 15 | This is a 1 question item where participants select very much improved (1) to very much worse (7). The lower the score the less pain. | week 6 (T2), week 15 (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Back Pain