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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AR076734-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work.
This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine).
In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study.
Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them.
The study hypothesizes the following:
that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).
In addition, the following mechanistic hypothesis and Aims are included:
Mindfulness-Based Stress Reduction:
Aim 2: the study predicts that patients with chronic low back pain (cLBP) will preferentially respond to this therapy if PROs indicate higher levels of pain catastrophizing, as measured by the Pain Catastrophizing Scale, or lower scores on the Experiences Questionnaire.
Aim 3: the study hypothesizes that cLBP patients with decreased activation in response to pain in the subgenual anterior cingulate cortex (sgACC) and Prefrontal Cortex and increased activation in somatosensory cortex (S1) and thalamus will respond preferentially to MBSR.
Physical Therapy (PT) and Exercise
Aim 2: The primary hypothesis for the light phenotyping protocol is those individuals with the highest scores on the Fear Avoidance Beliefs Questionnaire and lowest scores for PROMIS Self-Efficacy for Managing Symptoms will be most likely to improve from PT/Exercise program.
Aim 3: the study hypothesis that low vagal tone and high basal inflammation will predict responsiveness to the PT/Exercise program.
Acupressure:
Aim 2: The study hypothesizes that females with cLBP will respond better to acupressure than men, as will those with higher scores on the 2011 Fibromyalgia Survey Questionnaire.
Aim 3: The study predicts that cLBP patients with higher posterior insula glutamate and/or greater insula - Default Mode Network (DMN) connectivity (as well as increased DMN-S1 connectivity
Duloxetine:
Aim 2: the study hypothesizes that it will replicate previous studies suggesting that participants with cLBP will preferentially respond to this therapy if patient reported outcomes indicate stronger elements of either neuropathic pain (indicated by a high PainDETECT score) or centralized/nociplastic pain (indicated by more widespread pain on the 2011 Fibromyalgia Survey Questionnaire).
Aim 3: the study anticipates then that deficient pain inhibition on quantitative sensory testing, decreased periaqueductal gray (PAG)-insula connectivity, and elevated stimulated inflammatory responses will be associated with a positive response to centrally-acting duloxetine.
Additionally, a subset of individuals (n=160) from these groups will be asked to participate in an expanded phenotyping study that will include structural and functional brain neuroimaging, quantitative sensory testing (QST), plasma measures of inflammation, and digital measurement of autonomic tone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR (mindfulness-based stress reduction) | Experimental | Participants receiving MBSR during Treatment 1 or 2. |
|
| PT and exercise | Experimental | Participants receiving PT during Treatment 1 or 2. |
|
| Acupressure | Experimental | Participants receiving Acupresure during Treatment 1 or 2. |
|
| Duloxetine | Experimental | Participants receiving Duloxetine during Treatment 1 or 2. |
|
| Run-In | Experimental | Pre-treatment run-in period with access to the PainGuide self management platform. |
|
| Follow-Up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PainGuide | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3) | 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. | week 6 (T2), week 15 (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pain, Enjoyment, and General Activity Scale (PEG) From Week 6 (T2) to Week 15 (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. | week 6 (T2), week 15 (T3) |
| Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (T3) |
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Inclusion Criteria for Light Phenotyping (all participants):
Exclusion Criteria for Light Phenotyping (all participants):
Contraindications to Study Intervention: duloxetine
Contraindications to Study Intervention: Acupressure
Contraindications to Study Intervention: MBSR
Contraindications to Study Intervention: PT & Exercise
Inclusion Criteria for Deep Phenotyping (subset 160 participants):
Exclusion Criteria for Deep Phenotyping (subset 160 participants):
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| Name | Affiliation | Role |
|---|---|---|
| Afton Hassett, PsyD | University of Michigan | Principal Investigator |
| Daniel Clauw, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48170 | United States |
Data (including bio-specimens, omic data, raw imaging data, and other study data) will be shared with consortial partners. Data will be held at a Data Acquisition Center (DAC) hosted at the University of North Carolina. Omics data will be shared through NIH portals as required. Data dictionaries are harmonized across study sites and shared with consortial partners.
Per the study data sharing plan, data will be shared to the consortial DAC at fixed intervals after 20% completion is attained (and then at each subsequent 20%). The consortium currently plans for perpetual access for consortial partners.
The data will be available only to members of the consortium and is governed by a consortial data use agreement. Members must submit a request form for data access. The Data Access and Publications Committee will review requests and notify Data Access Team when access can be granted.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| T1 - Pre-Randomization: PainGuide run-in |
|
| ||||||||||||||||||
| T2 (Randomization) - T3 |
| |||||||||||||||||||
| T3 (Re-randomization) - T4 |
| |||||||||||||||||||
| T4 - T5 (Follow-Up) |
|
402 participants were randomized to a treatment at T2, but no baseline data on 2 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3) | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | week 6 (T2), week 15 (T3) |
|
T1(Week 1) to T5 (Week 36), approximately 9 months
In line with clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Afton Hassett, PsyD | University of Michigan | 734-763-5226 | afton@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2025 | Oct 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2025 | Oct 15, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2025 | Oct 14, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Sequential, multiple assignment, randomized trial (SMART) design
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Participants on Follow-Up at any timepoint throughout the study. |
| MBSR | Behavioral | 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. |
|
| PT and exercise | Behavioral | 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. |
|
| Self -administered acupressure | Device | 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. |
|
| Duloxetine | Drug | 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 | Device | 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. |
|
|
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. |
| week 15 (T3) |
| Screen Failure |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Attended Study Visit | Participants who attended T2 visit. |
|
| COMPLETED | Of those who attended T2 visit, participants who attended T3. |
|
| NOT COMPLETED |
|
|
| Attended Study Visit | Participants who attended T3 visit. Of note, there are participants that missed T2 but attended T3. This accounts for the difference in participants that completed T3/Period 2 and those that started T3/Period 3. |
|
| COMPLETED | Of those who attended T3 visit, participants who attended T4. |
|
| NOT COMPLETED |
|
|
| Attended Study Visit | Participants who attended T4 visit. Of note, there are participants that missed T3 but attended T4. This accounts for the difference in participants that completed T4/Period 3 and those that started T4/Period 4. |
|
| COMPLETED | Participants who attended T5 and final study visit. |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Collected through Qualtrics administered survey | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Relationship Status | Count of Participants | Participants |
|
| Pain Duration | 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. | Mean | Standard Deviation | months |
|
| Annual Household Income | Count of Participants | Participants |
|
| PROMIS Pain Interference | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Pain, Enjoyment of Life, and General Activity (PEG) | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Physical Function | The PROMIS physical function consists of 3 questions on a Likert scale ranging from 'Unable to Do" (1) to "Without any difficulty" (5) and 2 questions on a Likert scale ranging from "Cannot Do" to "Not at all". Total scores are between 6 and 30, with higher scores indicating increased physical function. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Sleep Disturbance | The PROMIS sleep disturbance consists of 5 questions on a Likert scale ranging from 'Not at all" (1) to "Very much" (5) and 1 question on a Likert scale ranging from 'Very good' (1) to 'Very poor' (5). Total scores are between 6 and 30, with higher scores indicating increased sleep disturbance. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Depression | The PROMIS depression consists of 4 questions on a Likert scale ranging from 'Never' (1) to 'Always' (5). Total scores are between 4 and 20, with higher scores indicating increased depression. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Anxiety | The PROMIS anxiety consists of 4 questions on a Likert scale ranging from 'Never' (1) to "Always" (5). Total scores are between 4 and 20, with higher scores indicating increased anxiety. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Fatigue | The PROMIS fatigue 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 fatigue. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Social Roles and Activities | The PROMIS Social Roles and Activities consists of 4 questions on a Likert scale ranging from 'Always" (1) to "Never" (5). Total scores are between 4 and 20, with higher scores indicating increased ability to participate in social activities. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Cognitive Function | The PROMIS cognitive function consists of 2 questions on a Likert scale ranging from 'Not at all" (1) to "Very much" (5). Total scores are between 2 and 10, with higher scores indicating increased cognitive function. | 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. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Pain Intensity | The PROMIS pain intensity consists of 1 question on a Likert scale ranging from 'No Pain" (0) to "Worst Imaginable Pain" (10). Total scores are between 0 and 10, with higher scores indicating increased pain intensity. | 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. | Mean | Standard Deviation | units on a scale |
|
| Michigan Body Map | The Michigan Body Map is assessed electronically and assesses number of regions the study participant has pain, 0 (No Chronic Pain) - 36 (All Pain Regions). | 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. | Mean | Standard Deviation | number of regions |
|
| Fibromyalgia Criteria | Participants meeting the 2016 Fibromyalgia Criteria.
| 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. | Count of Participants | Participants |
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| PainDetect | The PainDetect measure consists of 14 questions - 7 questions on a Likert scale ranging from 'Never" (0) to "Very strongly" (5), 2 body region questions, 1 y/n question assessing pain, 1 visual question assessing type of back pain, and 3 questions on a Likert scale ranging from "none" (0) to "Max" (10). Higher scores indicating increase back pain in more regions. | 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. | Mean | Standard Deviation | units on a scale |
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| General Sensitivity Scale (GSS-8) | GSS-8 measures sensitivity with 8 questions in a yes/no format. Scores range from 0 to 8 with higher scores indicating increased sensitivity. | Mean | Standard Deviation | units on a scale |
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| Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Questionnaire consists of 13 questions on a Likert scale ranging from 'Not at all" (0) to "All the time" (4). Total scores are between 0 and 52, with higher scores indicating increased catastrophizing. | 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. | Mean | Standard Deviation | units on a scale |
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| Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self Efficacy Quesionnaire (PSEQ) consists of 10 questions on a Likert scale ranging from 'Not at all confident" (0) to "Completely Confident" (6). Total scores are between 0 and 60, with higher scores indicating increased self efficacy. | 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. | Mean | Standard Deviation | units on a scale |
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| Fear Avoidance Belief Questionnaire (FAPQ) | The Fear Avoidance Belief Questionnaire consists of 16 questions on a Likert scale ranging from 'Completely Disagree" (0) to "Completely Agree" (6). Total scores are between 0 and 96, with higher scores indicating fear avoidance. | 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. | Mean | Standard Deviation | units on a scale |
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| Chronic Pain Acceptance Questionnaire (CPAQ) | The Chronic Pain Acceptance Questionnaire consists of 8 questions on a Likert scale ranging from 'Never" (0) to "Always true" (6). Total scores are between 0 and 48, with higher scores indicating increased pain acceptance. | 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. | Mean | Standard Deviation | units on a scale |
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| Experiences Questionnaire (EQ-11) | The Experiences Questionnaire (EQ-11) consists of 11 questions on a Likert scale ranging from 'Never' (1) to 'All the time' (5). Total scores are between 11 and 55. A higher total score indicates a greater ability to decenter, which is a positive indicator of detached observation of one's internal experiences. | 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. | Mean | Standard Deviation | units on a scale |
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| Perceived Stress Scale (PSS) | The Perceived Stress Scale consists of 10 questions on a Likert scale ranging from 'Never' (0) to 'Very often' (4). Total scores are between 0 and 40, with higher scores indicating increased perceived stress. | 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. | Mean | Standard Deviation | units on a scale |
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| Positive and Negative Affect Scale (PANAS) | The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure that assesses two distinct dimensions of mood: positive affect and negative affect. Participants rate the extent to which they have experienced each emotion over a specified time frame using a 5-point Likert scale - "Very slightly or not at all" (1) to "Extremely" (5). The PANAS score is separated into two subscales of Positive Affect (PA) and Negative Affect (NA), with a higher score indicating more positive or negative affect respectively. Each subscale ranges from 10-50. | 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. | Mean | Standard Deviation | units on a scale |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| Secondary | Change in the Pain, Enjoyment, and General Activity Scale (PEG) From Week 6 (T2) to Week 15 (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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | week 6 (T2), week 15 (T3) |
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|
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| Secondary | Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (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. | 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. | Posted | Count of Participants | Participants | week 15 (T3) |
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|
|
| 1 |
| 182 |
| 5 |
| 182 |
| 1 |
| 182 |
| EG001 | 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. | 0 | 175 | 8 | 175 | 1 | 175 |
| EG002 | 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. | 0 | 202 | 6 | 202 | 0 | 202 |
| EG003 | 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. | 0 | 282 | 3 | 167 | 40 | 282 |
| EG004 | Run-in Period | 5 week period leading up to randomization at T2 visit during which participants had access to the PainGuide self-managment program. | 0 | 494 | 9 | 494 | 4 | 494 |
| EG005 | On Follow-Up | 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. | 1 | 405 | 17 | 405 | 2 | 405 |
| Breast Cancer | Reproductive system and breast disorders | Systematic Assessment |
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| Knee Replacement | Surgical and medical procedures | Systematic Assessment |
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| Ideation | Psychiatric disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| General disorders | Systematic Assessment |
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| Car Accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Squamous Cell Carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Pacemaker | Surgical and medical procedures | Systematic Assessment |
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| Dizziness and Tingling Limbs | Nervous system disorders | Systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nose Surgery | Surgical and medical procedures | Systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dermatomyositis | Immune system disorders | Systematic Assessment |
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| Syncope | Vascular disorders | Systematic Assessment |
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| COVID | Infections and infestations | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Hernia Repair | Gastrointestinal disorders | Systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | Systematic Assessment |
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| Thrombectomy | Surgical and medical procedures | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cardiac Seizure | Cardiac disorders | Systematic Assessment |
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| Failure to Thrive | Gastrointestinal disorders | Systematic Assessment |
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| Lumbar Fusion | Surgical and medical procedures | Systematic Assessment |
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| DVT | Vascular disorders | Systematic Assessment |
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| TKA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Thyroplasty | Surgical and medical procedures | Systematic Assessment |
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| Wrist Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Finger Surgery | Surgical and medical procedures | Systematic Assessment |
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| Hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| TIA | Vascular disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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Not provided
Not provided
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Lower Secondary (Middle School) |
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| Upper Secondary (High School) |
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| Diploma or equivalent (GED) |
|
| Some College/ Certificate |
|
| Vocational/Trade School |
|
| Bachelor's degree |
|
| Some Graduate or Professional School |
|
| Graduate or Professional School diploma |
|
| Unknown |
|
| Part-time employment |
|
| Not employed |
|
| Retired |
|
| Unknown |
|
| Married |
|
| Never married |
|
| Separated |
|
| Widowed |
|
| Unknown |
|
| $10,000 - $24,999 |
|
| $25,000 - $34,999 |
|
| $35,000 - $49,999 |
|
| $50,000 - $74,999 |
|
| $75,000 - $99,999 |
|
| $100,000 - $149,999 |
|
| $150,000 - $199,999 |
|
| $200,000 or more |
|
| Prefer not to answer |
|
| Unknown |
|
|
| Score 3 or higher |
|