Trial Outcomes & Findings for The Back Pain Consortium Research Program Study (NCT NCT04870957)

Last Updated: 2025-12-05

Results Overview

The PROMIS pain interference consists of 4 questions on a Likert scale ranging from 'Not at all" (1) to "Very much" (5). Total scores are between 4 and 20, with higher scores indicating increased pain interference.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

494 participants

Primary outcome timeframe

week 6 (T2), week 15 (T3)

Results posted on

2025-12-05

Participant Flow

Participants were recruited from June 1, 2021-June 27, 2024, through Michigan Medicine clinics (Back \& Pain Center, Physical Medicine, Family Medicine, Neurosurgery) and community/online sources (UMHealthResearch.org, Facebook, MLive, flyers, radio). Of 6,965 screened, 494 eligible participants completed a baseline visit.

Participants completed a 4-week online PainGuide run-in before randomization. At T2, those with PGIC ≥ 2 were randomized to one of four 8-week treatments (MBSR, PT/exercise, acupressure, or duloxetine). Participants with PGIC \< 2 entered follow-up only and were not randomized. Screen failures were those who did not meet eligibility criteria were withdrawn from the study.

Participant milestones

Participant milestones
Measure	MBSR (mindfulness-based stress reduction) MBSR: 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. Pro-Diary monitor: 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.	PT and exercise PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine Duloxetine: 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. Pro-Diary monitor: 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.	Run-in Period Baseline visit to T2 visit. Pre-treatment with exposure to the PainGuide website platform. PainGuide: 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.	Follow-up This includes participants who are on follow-up due to one or more of the following reasons: Missed study visit timepoint (T2), On Follow-up/PGIC=1 at T2 or T3 visit, or post-treatment follow from T4 to T5 visit.
T1 - Pre-Randomization: PainGuide run-in STARTED	0	0	0	0	494	0
T1 - Pre-Randomization: PainGuide run-in COMPLETED	0	0	0	0	417	0
T1 - Pre-Randomization: PainGuide run-in NOT COMPLETED	0	0	0	0	77	0
T2 (Randomization) - T3 STARTED	102	102	102	96	0	15
T2 (Randomization) - T3 Attended Study Visit	102	102	102	96	0	3
T2 (Randomization) - T3 COMPLETED	79	90	79	83	0	2
T2 (Randomization) - T3 NOT COMPLETED	23	12	23	13	0	13
T3 (Re-randomization) - T4 STARTED	80	73	100	61	0	47
T3 (Re-randomization) - T4 Attended Study Visit	80	73	100	61	0	47
T3 (Re-randomization) - T4 COMPLETED	56	60	81	49	0	21
T3 (Re-randomization) - T4 NOT COMPLETED	24	13	19	12	0	26
T4 - T5 (Follow-Up) STARTED	0	0	0	0	0	304
T4 - T5 (Follow-Up) Attended Study Visit	0	0	0	0	0	277
T4 - T5 (Follow-Up) COMPLETED	0	0	0	0	0	274
T4 - T5 (Follow-Up) NOT COMPLETED	0	0	0	0	0	30

Reasons for withdrawal

Reasons for withdrawal
Measure	MBSR (mindfulness-based stress reduction) MBSR: 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. Pro-Diary monitor: 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.	PT and exercise PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine Duloxetine: 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. Pro-Diary monitor: 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.	Run-in Period Baseline visit to T2 visit. Pre-treatment with exposure to the PainGuide website platform. PainGuide: 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.	Follow-up This includes participants who are on follow-up due to one or more of the following reasons: Missed study visit timepoint (T2), On Follow-up/PGIC=1 at T2 or T3 visit, or post-treatment follow from T4 to T5 visit.
T1 - Pre-Randomization: PainGuide run-in Withdrawal by Subject	0	0	0	0	35	0
T1 - Pre-Randomization: PainGuide run-in Screen Failure	0	0	0	0	2	0
T1 - Pre-Randomization: PainGuide run-in Lost to Follow-up	0	0	0	0	37	0
T1 - Pre-Randomization: PainGuide run-in Physician Decision	0	0	0	0	3	0
T2 (Randomization) - T3 Adverse Event	1	1	0	0	0	0
T2 (Randomization) - T3 Lost to Follow-up	7	0	7	3	0	0
T2 (Randomization) - T3 Withdrawal by Subject	11	8	11	7	0	1
T2 (Randomization) - T3 Physician Decision	0	0	2	1	0	0
T2 (Randomization) - T3 Missed Timepoint	4	3	3	2	0	12
T3 (Re-randomization) - T4 Adverse Event	0	1	0	1	0	0
T3 (Re-randomization) - T4 Lost to Follow-up	8	6	7	6	0	2
T3 (Re-randomization) - T4 Withdrawal by Subject	11	5	10	3	0	1
T3 (Re-randomization) - T4 Physician Decision	2	0	0	0	0	0
T3 (Re-randomization) - T4 Missed Timepoint	3	1	2	2	0	23
T4 - T5 (Follow-Up) Lost to Follow-up	0	0	0	0	0	21
T4 - T5 (Follow-Up) Withdrawal by Subject	0	0	0	0	0	7
T4 - T5 (Follow-Up) Physician Decision	0	0	0	0	0	2

Baseline Characteristics

Pain duration was unknown on 3 participants in the Acupressure arm and 1 participant in the PT arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupressure n=101 Participants Self -administered acupressure: 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. Pro-Diary monitor: 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.	PT and Exercise n=102 Participants PT and exercise: 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. Pro-Diary monitor: 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.	MBSR (Mindfulness-based Stress Reduction) n=101 Participants MBSR: 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. Pro-Diary monitor: 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.	Duloxetine n=96 Participants Duloxetine: 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. Pro-Diary monitor: 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.	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	0 Participants n=96 Participants	0 Participants n=400 Participants
Age, Categorical Between 18 and 65 years	93 Participants n=101 Participants	79 Participants n=102 Participants	93 Participants n=101 Participants	84 Participants n=96 Participants	349 Participants n=400 Participants
Age, Categorical >=65 years	8 Participants n=101 Participants	23 Participants n=102 Participants	8 Participants n=101 Participants	12 Participants n=96 Participants	51 Participants n=400 Participants
Age, Continuous	49.0 years STANDARD_DEVIATION 11.9 • n=101 Participants	51.0 years STANDARD_DEVIATION 13.3 • n=102 Participants	50.2 years STANDARD_DEVIATION 10.7 • n=101 Participants	50.0 years STANDARD_DEVIATION 11.0 • n=96 Participants	50.2 years STANDARD_DEVIATION 11.8 • n=400 Participants
Sex: Female, Male Female	70 Participants n=101 Participants	68 Participants n=102 Participants	72 Participants n=101 Participants	63 Participants n=96 Participants	273 Participants n=400 Participants
Sex: Female, Male Male	31 Participants n=101 Participants	34 Participants n=102 Participants	29 Participants n=101 Participants	33 Participants n=96 Participants	127 Participants n=400 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=101 Participants	6 Participants n=102 Participants	5 Participants n=101 Participants	6 Participants n=96 Participants	26 Participants n=400 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=101 Participants	87 Participants n=102 Participants	87 Participants n=101 Participants	85 Participants n=96 Participants	345 Participants n=400 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=101 Participants	9 Participants n=102 Participants	9 Participants n=101 Participants	5 Participants n=96 Participants	29 Participants n=400 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=101 Participants	0 Participants n=102 Participants	1 Participants n=101 Participants	0 Participants n=96 Participants	2 Participants n=400 Participants
Race (NIH/OMB) Asian	11 Participants n=101 Participants	3 Participants n=102 Participants	10 Participants n=101 Participants	16 Participants n=96 Participants	40 Participants n=400 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	0 Participants n=96 Participants	0 Participants n=400 Participants
Race (NIH/OMB) Black or African American	23 Participants n=101 Participants	22 Participants n=102 Participants	16 Participants n=101 Participants	27 Participants n=96 Participants	88 Participants n=400 Participants
Race (NIH/OMB) White	54 Participants n=101 Participants	66 Participants n=102 Participants	64 Participants n=101 Participants	44 Participants n=96 Participants	228 Participants n=400 Participants
Race (NIH/OMB) More than one race	6 Participants n=101 Participants	7 Participants n=102 Participants	6 Participants n=101 Participants	7 Participants n=96 Participants	26 Participants n=400 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=101 Participants	4 Participants n=102 Participants	4 Participants n=101 Participants	2 Participants n=96 Participants	16 Participants n=400 Participants
Region of Enrollment United States	101 participants n=101 Participants	102 participants n=102 Participants	101 participants n=101 Participants	96 participants n=96 Participants	400 participants n=400 Participants
Education Primary (Elementary School)	0 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	0 Participants n=96 Participants	0 Participants n=400 Participants
Education Lower Secondary (Middle School)	0 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	1 Participants n=96 Participants	1 Participants n=400 Participants
Education Upper Secondary (High School)	3 Participants n=101 Participants	4 Participants n=102 Participants	5 Participants n=101 Participants	3 Participants n=96 Participants	15 Participants n=400 Participants
Education Diploma or equivalent (GED)	9 Participants n=101 Participants	5 Participants n=102 Participants	4 Participants n=101 Participants	8 Participants n=96 Participants	26 Participants n=400 Participants
Education Some College/ Certificate	26 Participants n=101 Participants	36 Participants n=102 Participants	28 Participants n=101 Participants	19 Participants n=96 Participants	109 Participants n=400 Participants
Education Vocational/Trade School	6 Participants n=101 Participants	6 Participants n=102 Participants	6 Participants n=101 Participants	4 Participants n=96 Participants	22 Participants n=400 Participants
Education Bachelor's degree	22 Participants n=101 Participants	22 Participants n=102 Participants	23 Participants n=101 Participants	20 Participants n=96 Participants	87 Participants n=400 Participants
Education Some Graduate or Professional School	6 Participants n=101 Participants	4 Participants n=102 Participants	11 Participants n=101 Participants	3 Participants n=96 Participants	24 Participants n=400 Participants
Education Graduate or Professional School diploma	28 Participants n=101 Participants	25 Participants n=102 Participants	24 Participants n=101 Participants	38 Participants n=96 Participants	115 Participants n=400 Participants
Education Unknown	1 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	0 Participants n=96 Participants	1 Participants n=400 Participants
Employment Status Full-time employment	46 Participants n=101 Participants	40 Participants n=102 Participants	45 Participants n=101 Participants	43 Participants n=96 Participants	174 Participants n=400 Participants
Employment Status Part-time employment	16 Participants n=101 Participants	12 Participants n=102 Participants	14 Participants n=101 Participants	17 Participants n=96 Participants	59 Participants n=400 Participants
Employment Status Not employed	18 Participants n=101 Participants	20 Participants n=102 Participants	21 Participants n=101 Participants	21 Participants n=96 Participants	80 Participants n=400 Participants
Employment Status Retired	19 Participants n=101 Participants	30 Participants n=102 Participants	21 Participants n=101 Participants	15 Participants n=96 Participants	85 Participants n=400 Participants
Employment Status Unknown	2 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	0 Participants n=96 Participants	2 Participants n=400 Participants
Relationship Status Divorced	24 Participants n=101 Participants	18 Participants n=102 Participants	19 Participants n=101 Participants	14 Participants n=96 Participants	75 Participants n=400 Participants
Relationship Status Married	48 Participants n=101 Participants	47 Participants n=102 Participants	55 Participants n=101 Participants	55 Participants n=96 Participants	205 Participants n=400 Participants
Relationship Status Never married	21 Participants n=101 Participants	31 Participants n=102 Participants	23 Participants n=101 Participants	18 Participants n=96 Participants	93 Participants n=400 Participants
Relationship Status Separated	3 Participants n=101 Participants	1 Participants n=102 Participants	1 Participants n=101 Participants	3 Participants n=96 Participants	8 Participants n=400 Participants
Relationship Status Widowed	4 Participants n=101 Participants	5 Participants n=102 Participants	3 Participants n=101 Participants	6 Participants n=96 Participants	18 Participants n=400 Participants
Relationship Status Unknown	1 Participants n=101 Participants	0 Participants n=102 Participants	0 Participants n=101 Participants	0 Participants n=96 Participants	1 Participants n=400 Participants
Pain Duration	113 months STANDARD_DEVIATION 155 • n=98 Participants • Pain duration was unknown on 3 participants in the Acupressure arm and 1 participant in the PT arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	133 months STANDARD_DEVIATION 216 • n=101 Participants • Pain duration was unknown on 3 participants in the Acupressure arm and 1 participant in the PT arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	126 months STANDARD_DEVIATION 183 • n=101 Participants • Pain duration was unknown on 3 participants in the Acupressure arm and 1 participant in the PT arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	145 months STANDARD_DEVIATION 418 • n=96 Participants • Pain duration was unknown on 3 participants in the Acupressure arm and 1 participant in the PT arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	129 months STANDARD_DEVIATION 262 • n=396 Participants • Pain duration was unknown on 3 participants in the Acupressure arm and 1 participant in the PT arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Annual Household Income Less than $10,000	4 Participants n=101 Participants	7 Participants n=102 Participants	5 Participants n=101 Participants	9 Participants n=96 Participants	25 Participants n=400 Participants
Annual Household Income $10,000 - $24,999	12 Participants n=101 Participants	15 Participants n=102 Participants	12 Participants n=101 Participants	9 Participants n=96 Participants	48 Participants n=400 Participants
Annual Household Income $25,000 - $34,999	8 Participants n=101 Participants	12 Participants n=102 Participants	10 Participants n=101 Participants	3 Participants n=96 Participants	33 Participants n=400 Participants
Annual Household Income $35,000 - $49,999	15 Participants n=101 Participants	14 Participants n=102 Participants	9 Participants n=101 Participants	9 Participants n=96 Participants	47 Participants n=400 Participants
Annual Household Income $50,000 - $74,999	16 Participants n=101 Participants	11 Participants n=102 Participants	13 Participants n=101 Participants	10 Participants n=96 Participants	50 Participants n=400 Participants
Annual Household Income $75,000 - $99,999	9 Participants n=101 Participants	5 Participants n=102 Participants	12 Participants n=101 Participants	7 Participants n=96 Participants	33 Participants n=400 Participants
Annual Household Income $100,000 - $149,999	14 Participants n=101 Participants	11 Participants n=102 Participants	12 Participants n=101 Participants	13 Participants n=96 Participants	50 Participants n=400 Participants
Annual Household Income $150,000 - $199,999	5 Participants n=101 Participants	5 Participants n=102 Participants	9 Participants n=101 Participants	9 Participants n=96 Participants	28 Participants n=400 Participants
Annual Household Income $200,000 or more	4 Participants n=101 Participants	5 Participants n=102 Participants	4 Participants n=101 Participants	11 Participants n=96 Participants	24 Participants n=400 Participants
Annual Household Income Prefer not to answer	12 Participants n=101 Participants	16 Participants n=102 Participants	14 Participants n=101 Participants	16 Participants n=96 Participants	58 Participants n=400 Participants
Annual Household Income Unknown	2 Participants n=101 Participants	1 Participants n=102 Participants	1 Participants n=101 Participants	0 Participants n=96 Participants	4 Participants n=400 Participants
PROMIS Pain Interference	14.8 units on a scale STANDARD_DEVIATION 3.2 • n=98 Participants • Pain Interference was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	14.9 units on a scale STANDARD_DEVIATION 3.5 • n=101 Participants • Pain Interference was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	15.5 units on a scale STANDARD_DEVIATION 3.0 • n=100 Participants • Pain Interference was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	14.8 units on a scale STANDARD_DEVIATION 3.4 • n=95 Participants • Pain Interference was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	15.0 units on a scale STANDARD_DEVIATION 3.3 • n=394 Participants • Pain Interference was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Pain, Enjoyment of Life, and General Activity (PEG)	6.4 units on a scale STANDARD_DEVIATION 1.8 • n=98 Participants • PEG was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.4 units on a scale STANDARD_DEVIATION 1.9 • n=101 Participants • PEG was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.6 units on a scale STANDARD_DEVIATION 1.5 • n=100 Participants • PEG was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.4 units on a scale STANDARD_DEVIATION 1.9 • n=95 Participants • PEG was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.4 units on a scale STANDARD_DEVIATION 1.8 • n=394 Participants • PEG was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Physical Function	17.5 units on a scale STANDARD_DEVIATION 4.7 • n=98 Participants • PROMIS Physical Function was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	17.3 units on a scale STANDARD_DEVIATION 4.9 • n=101 Participants • PROMIS Physical Function was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	16.8 units on a scale STANDARD_DEVIATION 4.1 • n=100 Participants • PROMIS Physical Function was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	17.8 units on a scale STANDARD_DEVIATION 5.3 • n=94 Participants • PROMIS Physical Function was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	17.3 units on a scale STANDARD_DEVIATION 4.7 • n=393 Participants • PROMIS Physical Function was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Sleep Disturbance	19.4 units on a scale STANDARD_DEVIATION 5.2 • n=98 Participants • PROMIS Sleep Disturbance was unknown on 3 participants in the Acupressure arm, 2 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	19.4 units on a scale STANDARD_DEVIATION 5.6 • n=100 Participants • PROMIS Sleep Disturbance was unknown on 3 participants in the Acupressure arm, 2 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	19.1 units on a scale STANDARD_DEVIATION 5.8 • n=100 Participants • PROMIS Sleep Disturbance was unknown on 3 participants in the Acupressure arm, 2 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	20.2 units on a scale STANDARD_DEVIATION 5.4 • n=95 Participants • PROMIS Sleep Disturbance was unknown on 3 participants in the Acupressure arm, 2 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	19.5 units on a scale STANDARD_DEVIATION 5.5 • n=393 Participants • PROMIS Sleep Disturbance was unknown on 3 participants in the Acupressure arm, 2 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Depression	8.6 units on a scale STANDARD_DEVIATION 4.3 • n=97 Participants • PROMIS Depression was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.1 units on a scale STANDARD_DEVIATION 3.9 • n=101 Participants • PROMIS Depression was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.3 units on a scale STANDARD_DEVIATION 3.8 • n=100 Participants • PROMIS Depression was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.8 units on a scale STANDARD_DEVIATION 3.8 • n=94 Participants • PROMIS Depression was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.2 units on a scale STANDARD_DEVIATION 3.9 • n=392 Participants • PROMIS Depression was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Anxiety	8.6 units on a scale STANDARD_DEVIATION 4.2 • n=97 Participants • PROMIS Anxiety was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.7 units on a scale STANDARD_DEVIATION 3.5 • n=101 Participants • PROMIS Anxiety was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.0 units on a scale STANDARD_DEVIATION 3.5 • n=100 Participants • PROMIS Anxiety was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.0 units on a scale STANDARD_DEVIATION 4.1 • n=94 Participants • PROMIS Anxiety was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.1 units on a scale STANDARD_DEVIATION 3.8 • n=392 Participants • PROMIS Anxiety was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Fatigue	12.9 units on a scale STANDARD_DEVIATION 4.6 • n=97 Participants • PROMIS Fatigue was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	12.3 units on a scale STANDARD_DEVIATION 4.5 • n=101 Participants • PROMIS Fatigue was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	12.3 units on a scale STANDARD_DEVIATION 4.4 • n=98 Participants • PROMIS Fatigue was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.9 units on a scale STANDARD_DEVIATION 4.6 • n=94 Participants • PROMIS Fatigue was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	12.3 units on a scale STANDARD_DEVIATION 4.5 • n=390 Participants • PROMIS Fatigue was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Social Roles and Activities	11.3 units on a scale STANDARD_DEVIATION 3.5 • n=97 Participants • Pain Interference was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.4 units on a scale STANDARD_DEVIATION 3.9 • n=101 Participants • Pain Interference was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.3 units on a scale STANDARD_DEVIATION 3.6 • n=98 Participants • Pain Interference was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.7 units on a scale STANDARD_DEVIATION 4.1 • n=94 Participants • Pain Interference was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.4 units on a scale STANDARD_DEVIATION 3.8 • n=390 Participants • Pain Interference was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Cognitive Function	7.1 units on a scale STANDARD_DEVIATION 1.9 • n=97 Participants • PROMIS Cognitive Function was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 4 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.2 units on a scale STANDARD_DEVIATION 1.9 • n=101 Participants • PROMIS Cognitive Function was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 4 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.3 units on a scale STANDARD_DEVIATION 2.0 • n=97 Participants • PROMIS Cognitive Function was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 4 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.2 units on a scale STANDARD_DEVIATION 2.3 • n=94 Participants • PROMIS Cognitive Function was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 4 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.2 units on a scale STANDARD_DEVIATION 2.0 • n=389 Participants • PROMIS Cognitive Function was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 4 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PROMIS Pain Intensity	6.1 units on a scale STANDARD_DEVIATION 1.6 • n=97 Participants • PROMIS Pain Intensity was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.4 units on a scale STANDARD_DEVIATION 1.7 • n=101 Participants • PROMIS Pain Intensity was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.4 units on a scale STANDARD_DEVIATION 1.5 • n=98 Participants • PROMIS Pain Intensity was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.3 units on a scale STANDARD_DEVIATION 1.9 • n=94 Participants • PROMIS Pain Intensity was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.3 units on a scale STANDARD_DEVIATION 1.7 • n=390 Participants • PROMIS Pain Intensity was unknown on 3 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Michigan Body Map	8.8 number of regions STANDARD_DEVIATION 6.3 • n=97 Participants • The Michigan Body Map was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 2 participants in the MBSR arm, and 2 participants in the duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.3 number of regions STANDARD_DEVIATION 6.3 • n=101 Participants • The Michigan Body Map was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 2 participants in the MBSR arm, and 2 participants in the duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.7 number of regions STANDARD_DEVIATION 6.4 • n=99 Participants • The Michigan Body Map was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 2 participants in the MBSR arm, and 2 participants in the duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.1 number of regions STANDARD_DEVIATION 6.6 • n=94 Participants • The Michigan Body Map was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 2 participants in the MBSR arm, and 2 participants in the duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	8.5 number of regions STANDARD_DEVIATION 6.4 • n=391 Participants • The Michigan Body Map was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 2 participants in the MBSR arm, and 2 participants in the duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Fibromyalgia Criteria	17 Participants n=97 Participants • 2016 Fibromyalgia Criteria was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	21 Participants n=101 Participants • 2016 Fibromyalgia Criteria was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	20 Participants n=98 Participants • 2016 Fibromyalgia Criteria was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	20 Participants n=94 Participants • 2016 Fibromyalgia Criteria was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	78 Participants n=390 Participants • 2016 Fibromyalgia Criteria was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
PainDetect	11.3 units on a scale STANDARD_DEVIATION 7.3 • n=97 Participants • PainDetect was unknown on 4 participants in the Acupressure arm, 5 participants in the PT arm, 5 participants in the MBSR arm, and 6 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	10.9 units on a scale STANDARD_DEVIATION 6.9 • n=97 Participants • PainDetect was unknown on 4 participants in the Acupressure arm, 5 participants in the PT arm, 5 participants in the MBSR arm, and 6 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.8 units on a scale STANDARD_DEVIATION 7.7 • n=96 Participants • PainDetect was unknown on 4 participants in the Acupressure arm, 5 participants in the PT arm, 5 participants in the MBSR arm, and 6 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.8 units on a scale STANDARD_DEVIATION 8.1 • n=90 Participants • PainDetect was unknown on 4 participants in the Acupressure arm, 5 participants in the PT arm, 5 participants in the MBSR arm, and 6 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.5 units on a scale STANDARD_DEVIATION 7.5 • n=380 Participants • PainDetect was unknown on 4 participants in the Acupressure arm, 5 participants in the PT arm, 5 participants in the MBSR arm, and 6 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
General Sensitivity Scale (GSS-8)	2.0 units on a scale STANDARD_DEVIATION 2.1 • n=101 Participants	2.0 units on a scale STANDARD_DEVIATION 1.9 • n=102 Participants	1.7 units on a scale STANDARD_DEVIATION 1.9 • n=101 Participants	1.7 units on a scale STANDARD_DEVIATION 1.9 • n=96 Participants	1.9 units on a scale STANDARD_DEVIATION 2.0 • n=400 Participants
Pain Catastrophizing Scale (PCS)	12.4 units on a scale STANDARD_DEVIATION 5.3 • n=97 Participants • Pain Catastrophizing Scale (PCS) was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	11.5 units on a scale STANDARD_DEVIATION 5.7 • n=101 Participants • Pain Catastrophizing Scale (PCS) was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	12.0 units on a scale STANDARD_DEVIATION 5.0 • n=100 Participants • Pain Catastrophizing Scale (PCS) was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	12.1 units on a scale STANDARD_DEVIATION 6.2 • n=95 Participants • Pain Catastrophizing Scale (PCS) was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	12.0 units on a scale STANDARD_DEVIATION 5.6 • n=393 Participants • Pain Catastrophizing Scale (PCS) was unknown on 4 participants in the Acupressure arm, 1 participant in the PT arm, 1 participant in the MBSR arm, and 1 participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Pain Self Efficacy Questionnaire (PSEQ)	6.9 units on a scale STANDARD_DEVIATION 3.0 • n=97 Participants • Pain Self Efficacy Questionnaire (PSEQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.3 units on a scale STANDARD_DEVIATION 3.2 • n=100 Participants • Pain Self Efficacy Questionnaire (PSEQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.0 units on a scale STANDARD_DEVIATION 3.0 • n=98 Participants • Pain Self Efficacy Questionnaire (PSEQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.3 units on a scale STANDARD_DEVIATION 3.0 • n=94 Participants • Pain Self Efficacy Questionnaire (PSEQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	7.1 units on a scale STANDARD_DEVIATION 3.1 • n=389 Participants • Pain Self Efficacy Questionnaire (PSEQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 3 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Fear Avoidance Belief Questionnaire (FAPQ)	15.1 units on a scale STANDARD_DEVIATION 4.9 • n=97 Participants • Fear Avoidance Belief Questionnaire (FABQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	15.4 units on a scale STANDARD_DEVIATION 4.9 • n=100 Participants • Fear Avoidance Belief Questionnaire (FABQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	15.9 units on a scale STANDARD_DEVIATION 4.3 • n=96 Participants • Fear Avoidance Belief Questionnaire (FABQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	15.6 units on a scale STANDARD_DEVIATION 5.3 • n=93 Participants • Fear Avoidance Belief Questionnaire (FABQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	15.5 units on a scale STANDARD_DEVIATION 4.9 • n=386 Participants • Fear Avoidance Belief Questionnaire (FABQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Chronic Pain Acceptance Questionnaire (CPAQ)	24.2 units on a scale STANDARD_DEVIATION 7.5 • n=97 Participants • Chronic Pain Acceptance Questionnaire (CPAQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	24.6 units on a scale STANDARD_DEVIATION 7.8 • n=100 Participants • Chronic Pain Acceptance Questionnaire (CPAQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	24.0 units on a scale STANDARD_DEVIATION 8.0 • n=95 Participants • Chronic Pain Acceptance Questionnaire (CPAQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	24.1 units on a scale STANDARD_DEVIATION 7.1 • n=94 Participants • Chronic Pain Acceptance Questionnaire (CPAQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	24.2 units on a scale STANDARD_DEVIATION 7.6 • n=386 Participants • Chronic Pain Acceptance Questionnaire (CPAQ) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 2 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Experiences Questionnaire (EQ-11)	39.1 units on a scale STANDARD_DEVIATION 7.3 • n=94 Participants • Experiences Questionnaire was unknown on 5 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 4 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	39.8 units on a scale STANDARD_DEVIATION 7.5 • n=100 Participants • Experiences Questionnaire was unknown on 5 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 4 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	38.9 units on a scale STANDARD_DEVIATION 7.7 • n=95 Participants • Experiences Questionnaire was unknown on 5 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 4 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	40.5 units on a scale STANDARD_DEVIATION 7.4 • n=92 Participants • Experiences Questionnaire was unknown on 5 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 4 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	39.6 units on a scale STANDARD_DEVIATION 7.5 • n=381 Participants • Experiences Questionnaire was unknown on 5 participants in the Acupressure arm, 2 participants in the PT arm, 6 participants in the MBSR arm, and 4 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Perceived Stress Scale (PSS)	6.2 units on a scale STANDARD_DEVIATION 3.4 • n=97 Participants • Perceived Stress Scale was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 2 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	5.8 units on a scale STANDARD_DEVIATION 3.1 • n=100 Participants • Perceived Stress Scale was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 2 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.2 units on a scale STANDARD_DEVIATION 3.4 • n=98 Participants • Perceived Stress Scale was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 2 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.0 units on a scale STANDARD_DEVIATION 3.4 • n=93 Participants • Perceived Stress Scale was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 2 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	6.1 units on a scale STANDARD_DEVIATION 3.3 • n=388 Participants • Perceived Stress Scale was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 2 participants in the MBSR arm, and 3 participants in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Positive and Negative Affect Scale (PANAS) Positive Affect	30.5 units on a scale STANDARD_DEVIATION 8.1 • n=97 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	31.0 units on a scale STANDARD_DEVIATION 8.6 • n=100 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	31.1 units on a scale STANDARD_DEVIATION 8.0 • n=96 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	31.6 units on a scale STANDARD_DEVIATION 8.4 • n=92 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	31.0 units on a scale STANDARD_DEVIATION 8.3 • n=385 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.
Positive and Negative Affect Scale (PANAS) Negative Affect	21.3 units on a scale STANDARD_DEVIATION 8.5 • n=97 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	19.3 units on a scale STANDARD_DEVIATION 7.1 • n=100 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	20.3 units on a scale STANDARD_DEVIATION 7.6 • n=96 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	18.7 units on a scale STANDARD_DEVIATION 7.5 • n=91 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.	19.9 units on a scale STANDARD_DEVIATION 7.7 • n=384 Participants • Positive and Negative Affect Scale (PANAS) was unknown on 4 participants in the Acupressure arm, 2 participants in the PT arm, 5 participants in the MBSR arm, and 4/5 (positive/negative) participant in the Duloxetine arm. This question was not required, so patients could choose not to answer. This is reflected in the number analyzed category.

PRIMARY outcome

Timeframe: week 6 (T2), week 15 (T3)

Population: Of the 402 participants who were randomized to a treatment, 331 who completed the T3 study visit were analyzed. Participants excluded from this analysis are those who did not complete either T2 or T3.

Outcome measures

Outcome measures
Measure	MBSR (mindfulness-based stress reduction) n=79 Participants MBSR: 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. Pro-Diary monitor: 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.	PT and exercise n=90 Participants PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure n=79 Participants Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine n=83 Participants Duloxetine: 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. Pro-Diary monitor: 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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3)	-0.9 score on a scale Interval -1.5 to -0.37	-1.8 score on a scale Interval -2.4 to -1.1	-1.6 score on a scale Interval -2.5 to -0.74	-2.0 score on a scale Interval -2.8 to -1.3

SECONDARY outcome

Timeframe: week 6 (T2), week 15 (T3)

Population: Of the 402 randomized participants, 331 who completed T3 study visit were analyzed. Participants excluded from this analysis are those who did not complete either T2 or T3.

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.

Outcome measures

Outcome measures
Measure	MBSR (mindfulness-based stress reduction) n=79 Participants MBSR: 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. Pro-Diary monitor: 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.	PT and exercise n=90 Participants PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure n=79 Participants Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine n=83 Participants Duloxetine: 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. Pro-Diary monitor: 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.
Change in the Pain, Enjoyment, and General Activity Scale (PEG) From Week 6 (T2) to Week 15 (T3)	-1.0 score on a scale Interval -1.4 to -0.63	-1.5 score on a scale Interval -1.8 to -1.1	-0.5 score on a scale Interval -0.86 to -0.24	-1.2 score on a scale Interval -1.7 to -0.8

SECONDARY outcome

Timeframe: week 15 (T3)

Population: Of the 402 randomized participants, 331 who completed T3 study visit were analyzed. Participants excluded from this analysis are those who did not complete either T2 or T3.

This is a 1 question item where participants described their perceived improvement between T2 and T3 by selecting a score between 1 and 7, where 1 indicated "very much improved" and 7 indicated "very much worse. The lower the score, the greater improvement in perceived pain. Data is presented as count of participants who scored their improvement as a 1 or a 2 and those who scored their improvement as 3 or higher.

Outcome measures

Outcome measures
Measure	MBSR (mindfulness-based stress reduction) n=79 Participants MBSR: 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. Pro-Diary monitor: 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.	PT and exercise n=90 Participants PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure n=79 Participants Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine n=83 Participants Duloxetine: 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. Pro-Diary monitor: 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.
Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (T3) Very much (score of 1) /much improved (score of 2)	4 Participants	35 Participants	21 Participants	21 Participants
Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (T3) Score 3 or higher	75 Participants	55 Participants	58 Participants	62 Participants

Adverse Events

MBSR (mindfulness-based stress reduction)

Serious events: 5 serious events

Other events: 1 other events

Deaths: 1 deaths

PT and exercise

Serious events: 8 serious events

Other events: 1 other events

Deaths: 0 deaths

Acupressure

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Duloxetine

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Run-in Period

Serious events: 9 serious events

Other events: 4 other events

Deaths: 0 deaths

On Follow-Up

Serious events: 17 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	MBSR (mindfulness-based stress reduction) n=182 participants at risk MBSR: 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. Pro-Diary monitor: 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.	PT and exercise n=175 participants at risk PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure n=202 participants at risk Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine n=282 participants at risk；n=167 participants at risk Duloxetine: 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. Pro-Diary monitor: 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.	Run-in Period n=494 participants at risk 5 week period leading up to randomization at T2 visit during which participants had access to the PainGuide self-managment program.	On Follow-Up n=405 participants at risk Participants who were on follow-up due to PGIC=1 at T2 or T3, the week between treatment 1 and 2 or post treatment 2.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Nose Surgery	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.50% 1/202 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.50% 1/202 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Immune system disorders Dermatomyositis	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.60% 1/167 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Vascular disorders Syncope	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.60% 1/167 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Infections and infestations COVID	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Gastrointestinal disorders Diverticulitis	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Gastrointestinal disorders Hernia Repair	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Cholecystectomy	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Thrombectomy	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
General disorders	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Car Accident	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Squamous Cell Carcinoma	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Knee Replacement	0.55% 1/182 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Psychiatric disorders Ideation	0.55% 1/182 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Vascular disorders Stroke	0.55% 1/182 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Gastrointestinal disorders Ulcer	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Vascular disorders Hypertension	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Cardiac disorders Chest Pain	0.55% 1/182 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	1.1% 2/175 • Number of events 2 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.50% 1/202 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.40% 2/494 • Number of events 2 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Reproductive system and breast disorders Breast Cancer	0.55% 1/182 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Blood and lymphatic system disorders Anemia	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Pacemaker	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.50% 1/202 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Nervous system disorders Dizziness and Tingling Limbs	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.50% 1/202 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.50% 1/202 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.60% 1/167 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.74% 3/405 • Number of events 3 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Cardiac disorders Cardiac Seizure	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Gastrointestinal disorders Failure to Thrive	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Lumbar Fusion	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Vascular disorders DVT	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders TKA	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Thyroplasty	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Wrist Pain	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Surgical and medical procedures Finger Surgery	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Reproductive system and breast disorders Hysterectomy	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Infections and infestations Pneumonia	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Vascular disorders TIA	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/494 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/167 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/405 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.

Other adverse events

Other adverse events
Measure	MBSR (mindfulness-based stress reduction) n=182 participants at risk MBSR: 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. Pro-Diary monitor: 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.	PT and exercise n=175 participants at risk PT and exercise: 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. Pro-Diary monitor: 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.	Acupressure n=202 participants at risk Self -administered acupressure: 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. Pro-Diary monitor: 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.	Duloxetine n=282 participants at risk；n=167 participants at risk Duloxetine: 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. Pro-Diary monitor: 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.	Run-in Period n=494 participants at risk 5 week period leading up to randomization at T2 visit during which participants had access to the PainGuide self-managment program.	On Follow-Up n=405 participants at risk Participants who were on follow-up due to PGIC=1 at T2 or T3, the week between treatment 1 and 2 or post treatment 2.
General disorders Fatigue	0.00% 0/182 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/175 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	4.6% 13/282 • Number of events 13 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.20% 1/494 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea	0.55% 1/182 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.57% 1/175 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.00% 0/202 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	9.6% 27/282 • Number of events 27 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.61% 3/494 • Number of events 3 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.	0.25% 1/405 • Number of events 1 • T1(Week 1) to T5 (Week 36), approximately 9 months In line with clinicaltrials.gov definitions.

Additional Information

Afton Hassett, PsyD

University of Michigan

Phone: 734-763-5226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place