Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function

Abstract Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.

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Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain

Journal of Pain Research ◽

10.2147/jpr.s266455 ◽

2020 ◽

Vol Volume 13 ◽

pp. 2255-2265

Author(s):

Jonathan Greenberg ◽

Ryan A Mace ◽

Paula J Popok ◽

Ronald J Kulich ◽

Kushang V Patel ◽

...

Keyword(s):

Chronic Pain ◽

Physical Function ◽

Psychosocial Correlates ◽

Patient Reported ◽

Objective Performance

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A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial

JMIR Formative Research ◽

10.2196/18703 ◽

2020 ◽

Vol 4 (6) ◽

pp. e18703 ◽

Cited By ~ 3

Author(s):

Jonathan Greenberg ◽

Paula J Popok ◽

Ann Lin ◽

Ronald J Kulich ◽

Peter James ◽

...

Keyword(s):

Chronic Pain ◽

Physical Function ◽

Effect Size ◽

Controlled Trial ◽

Walk Test ◽

Randomized Controlled ◽

Emotional Function ◽

Activity Program ◽

Digital Monitoring ◽

Objectively Measured

Background Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. Objective This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. Methods Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. Results Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. Conclusions These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. Trial Registration ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916

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Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

JMIR Research Protocols ◽

10.2196/25351 ◽

2021 ◽

Vol 10 (1) ◽

pp. e25351

Author(s):

Ryan A Mace ◽

James D Doorley ◽

Paula J Popok ◽

Ana-Maria Vranceanu

Keyword(s):

Older Adults ◽

Chronic Pain ◽

Cognitive Decline ◽

Cognitive Functions ◽

Self Report ◽

Treatment Manual ◽

Pain Clinic ◽

Live Video ◽

Activity Program ◽

Body Activity

Background Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. Trial Registration ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 International Registered Report Identifier (IRRID) DERR1-10.2196/25351

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A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial (Preprint)

10.2196/preprints.18703 ◽

2020 ◽

Author(s):

Jonathan Greenberg ◽

Paula J Popok ◽

Ann Lin ◽

Ronald J Kulich ◽

Peter James ◽

...

Keyword(s):

Chronic Pain ◽

Physical Function ◽

Effect Size ◽

Controlled Trial ◽

Walk Test ◽

Randomized Controlled ◽

Emotional Function ◽

Activity Program ◽

Digital Monitoring ◽

Objectively Measured

BACKGROUND Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. METHODS Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. CLINICALTRIAL ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916

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Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study (Preprint)

10.2196/preprints.25351 ◽

2020 ◽

Author(s):

Ryan A Mace ◽

James D Doorley ◽

Paula J Popok ◽

Ana-Maria Vranceanu

Keyword(s):

Older Adults ◽

Chronic Pain ◽

Cognitive Decline ◽

Cognitive Functions ◽

Self Report ◽

Treatment Manual ◽

Pain Clinic ◽

Live Video ◽

Activity Program ◽

Body Activity

BACKGROUND Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. OBJECTIVE We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. METHODS This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). RESULTS The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). CONCLUSIONS Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. CLINICALTRIAL ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/25351

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A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain

Complementary Therapies in Clinical Practice ◽

10.1016/j.ctcp.2021.101410 ◽

2021 ◽

pp. 101410

Author(s):

Paula J. Popok ◽

Jonathan Greenberg ◽

Melissa V. Gates ◽

Ana-Maria Vranceanu

Keyword(s):

Chronic Pain ◽

Activity Measurement ◽

Qualitative Investigation ◽

Activity Program ◽

Body Activity

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Impact of Preoperative Opioid Use on 2-Year Patient-Reported Outcomes in Knee Surgery Patients

The Journal of Knee Surgery ◽

10.1055/s-0040-1716358 ◽

2020 ◽

Author(s):

Ali Aneizi ◽

Patrick M. J. Sajak ◽

Aymen Alqazzaz ◽

Tristan Weir ◽

Cameran I. Burt ◽

...

Keyword(s):

Physical Function ◽

Patient Reported Outcomes ◽

Knee Surgery ◽

The Body ◽

Pain Interference ◽

Opioid Use ◽

Opioid Prescription ◽

Social Satisfaction ◽

Patient Reported ◽

Met Expectations

AbstractThe objectives of this study are to assess perioperative opioid use in patients undergoing knee surgery and to examine the relationship between preoperative opioid use and 2-year postoperative patient-reported outcomes (PROs). We hypothesized that preoperative opioid use and, more specifically, higher quantities of preoperative opioid use would be associated with worse PROs in knee surgery patients. We studied 192 patients undergoing knee surgery at a single urban institution. Patients completed multiple PRO measures preoperatively and 2-year postoperatively, including six patient-reported outcomes measurement information system (PROMIS) domains; the International Knee Documentation Committee (IKDC) questionnaire, numeric pain scale (NPS) scores for the operative knee and the rest of the body, Marx's knee activity rating scale, Tegner's activity scale, International Physical Activity Questionnaire, as well as measures of met expectations, overall improvement, and overall satisfaction. Total morphine equivalents (TMEs) were calculated from a regional prescription monitoring program. Eighty patients (41.7%) filled an opioid prescription preoperatively, and refill TMEs were significantly higher in this subpopulation. Opioid use was associated with unemployment, government insurance, smoking, depression, history of prior surgery, higher body mass index, greater comorbidities, and lower treatment expectations. Preoperative opioid use was associated with significantly worse 2-year scores on most PROs, including PROMIS physical function, pain interference, fatigue, social satisfaction, IKDC, NPS for the knee and rest of the body, and Marx's and Tegner's scales. There was a significant dose-dependent association between greater preoperative TMEs and worse scores for PROMIS physical function, pain interference, fatigue, social satisfaction, NPS body, and Marx's and Tegner's scales. Multivariable analysis confirmed that any preoperative opioid use, but not quantity of TMEs, was an independent predictor of worse 2-year scores for function, activity, and knee pain. Preoperative opioid use and TMEs were neither independent predictors of met expectations, satisfaction, patient-perceived improvement, nor improvement on any PROs. Our findings demonstrate that preoperative opioid use is associated with clinically relevant worse patient-reported knee function and pain after knee surgery.

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Collecting patient reported outcomes to facilitate prescription opioid management: Development and testing of the Opioid Management App (OM-App) (Preprint)

10.2196/preprints.23633 ◽

2020 ◽

Author(s):

Jessica Robinson-Papp ◽

Gabriela Cedillo ◽

Richa Deshpande ◽

Mary Catherine George ◽

Qiuchen Yang ◽

...

Keyword(s):

Chronic Pain ◽

Pain Intensity ◽

Risk Behaviors ◽

Digital Health ◽

Monitoring Program ◽

Prescription Opioid ◽

Research Database ◽

Cross Sectional ◽

Study Duration ◽

Patient Reported

BACKGROUND Collecting patient-reported data needed by clinicians to adhere to opioid prescribing guidelines represents a significant time burden. OBJECTIVE We developed and tested an opioid management app (OM-App) to collect these data directly from patients. METHODS OM-App used a pre-existing digital health platform to deliver daily questions to patients via text-message and organize responses into a dashboard. We pilot tested OM-App over 9 months in 40 diverse participants with HIV who were prescribed opioids for chronic pain. Feasibility outcomes included: ability to export/integrate OM-App data with other research data; patient-reported barriers and adherence to OM-App use; capture of opioid-related harms, risk behaviors and pain intensity/interference; comparison of OM-App data to urine drug testing, prescription drug monitoring program data, and validated questionnaires. RESULTS OM-App data was exported/integrated into the research database after minor modifications. Thirty-nine of 40 participants were able to use OM-App, and over the study duration 70% of all OM-App questions were answered. Although the cross-sectional prevalence of opioid-related harms and risk behaviors reported via OM-App was low, some of these were not obtained via the other measures, and over the study duration all queried harms/risks were reported at least once via OM-App. Clinically meaningful changes in pain intensity/interference were captured. CONCLUSIONS OM-App was used by our diverse patient population to produce clinically relevant opioid- and pain-related data, which was successfully exported and integrated into a research database. These findings suggest that OM-App may be a useful tool for remote monitoring of patients prescribed opioids for chronic pain. CLINICALTRIAL NCT03669939 INTERNATIONAL REGISTERED REPORT RR2-doi:10.1016/j.conctc.2019.100468

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Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain

Journal of Clinical Psychology in Medical Settings ◽

10.1007/s10880-020-09758-w ◽

2021 ◽

Author(s):

Jonathan Greenberg ◽

Ann Lin ◽

Paula J. Popok ◽

Ronald J. Kulich ◽

Robert R. Edwards ◽

...

Keyword(s):

Chronic Pain ◽

Case Illustration ◽

Activity Program ◽

Group Mind

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