scholarly journals A Live Video Program to Prevent Chronic Pain and Disability in At-Risk Adults With Acute Orthopedic Injuries (Toolkit for Optimal Recovery): Protocol for a Multisite Feasibility Study

10.2196/28155 ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. e28155
Author(s):  
Ana-Maria Vranceanu ◽  
Jafar Bakhshaie ◽  
Mira Reichman ◽  
James Doorley ◽  
A Rani Elwy ◽  
...  

Background Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial. Objective The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. In this paper, we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation. Methods This study will be conducted at 3 geographically diverse level 1 trauma centers, anonymized as sites A, B, and C. We will conduct a multisite feasibility RCT of TOR versus the minimally enhanced usual care (MEUC) control (60 patients per site; 30 per arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury or surgery (baseline). Participants randomized to the TOR will receive a 4-session mind-body treatment delivered via a secure live video by trained clinical psychologists. Participants randomized to the MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes will be assessed at baseline, posttreatment, and at the 3-month follow-up. Results Enrollment for the RCT is estimated to begin in June 2021. The target date of completion of the feasibility RCT is April 2024. The institutional review board approval has been obtained (January 2020). Conclusions This investigation examines the multisite feasibility of TOR administered via live videoconferencing in adult patients with acute orthopedic injuries. If feasible, the next step is a multisite, hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a new way to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries who are at risk for chronic pain and disability. International Registered Report Identifier (IRRID) PRR1-10.2196/28155

2021 ◽  
Author(s):  
Ana-Maria Vranceanu ◽  
Jafar Bakhshaie ◽  
Mira Reichman ◽  
James Doorley ◽  
A Rani Elwy ◽  
...  

BACKGROUND Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial. OBJECTIVE The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. In this paper, we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation. METHODS This study will be conducted at 3 geographically diverse level 1 trauma centers, anonymized as sites A, B, and C. We will conduct a multisite feasibility RCT of TOR versus the minimally enhanced usual care (MEUC) control (60 patients per site; 30 per arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury or surgery (baseline). Participants randomized to the TOR will receive a 4-session mind-body treatment delivered via a secure live video by trained clinical psychologists. Participants randomized to the MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes will be assessed at baseline, posttreatment, and at the 3-month follow-up. RESULTS Enrollment for the RCT is estimated to begin in June 2021. The target date of completion of the feasibility RCT is April 2024. The institutional review board approval has been obtained (January 2020). CONCLUSIONS This investigation examines the multisite feasibility of TOR administered via live videoconferencing in adult patients with acute orthopedic injuries. If feasible, the next step is a multisite, hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a new way to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries who are at risk for chronic pain and disability. CLINICALTRIAL INTERNATIONAL REGISTERED REPORT PRR1-10.2196/28155


2021 ◽  
Author(s):  
James D Doorley ◽  
Ryan A Mace ◽  
Paula J Popok ◽  
Victoria A Grunberg ◽  
Anya Ragnhildstveit ◽  
...  

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.


2021 ◽  
Author(s):  
Antonio Varela

Abstract Background Chronic pain in all its forms and the accompanying level of disability is a healthcare crisis that reaches epidemic proportions and is considered a world level crisis. Chronic non-specific low back pain contributes a significant proportion of chronic pain. Specific psychosocial factors and their influence on reported disability in a chronic non-specific low back pain (CNLBP) population was researched. Methods Psychosocial factors examined include fear, catastrophizing, depression, and pain self-efficacy. This cross-sectional correlational study examined the mediating role between pain self-efficacy and the specific psychosocial factors with reported disability. The study included 90 participants with CNLBP between 20 and 60 years of age. Participants completed the Fear Avoidance Belief Questionnaire, The Pain Catastrophizing Scale, The Patient Health Questionnaire-9, The Pain Self-Efficacy Questionnaire, and The Lumbar Oswestry Disability Index to measure fear of physical activity, pain catastrophizing, depression, pain self-efficacy, and reported disability, respectively. The study used multivariate regression and mediation analyses. Results The principal finding of the study was a strong inverse relationship between pain self-efficacy and reported disability. Further, pain self-efficacy was considered a statistic mediator for all psychosocial factors investigated within this data set. Pain self-efficacy was strongly considered to have a mediating role between reported fear of physical activity and disability, reported pain catastrophizing and disability, and reported depression and disability. Additionally, adjusting for age and reported pain levels proved to be statistically significant, and it did not alter the role of pain self-efficacy. Conclusion The results identified that pain self-efficacy had a mediating role in the relationship between the specific psychosocial factors of fear, catastrophizing, and depression and reported disability. Pain self-efficacy plays a more significant role in the relationships between specific psychosocial factors and reported disability with CNLBP than previously considered.


2007 ◽  
Vol 17 (1) ◽  
pp. 15-18
Author(s):  
Ginger Garner

Thanks to IAYT, Yoga therapists have a forum where we can find one another, collaborate, research, educate the public, and have a professional association to call home. IAYT's mission is to establish Yoga as a recognized and respected therapy. I fully support and believe in IAYT's mission. I am a practitioner of Yoga therapy, combining physical therapy, Yoga, and Ayurveda to specialize in women's health, chronic pain, and orthopedic injuries, and am the founder and director of a Yoga therapist training program. Having wellfamiliarized myself with the definitions of Yoga therapy from each of the current Yoga therapy programs in the U.S., and having followed the discussions about standards in Yoga therapy on the Integrator Blog (theintegratorblog.com) and in IAYT's publications, I humbly offer what I believe would be a positive step in the future of the recognition of Yoga therapy as a healing therapeutic discipline in the U.S.


Author(s):  
Catherine Zaidel ◽  
Shirley Musich ◽  
Jaycee Karl ◽  
Sandra Kraemer ◽  
Charlotte S. Yeh

Author(s):  
Ye Zhang ◽  
Dmitry V. Lukyanenko ◽  
Anatoly G. Yagola

AbstractIn this article, we consider an inverse problem for the integral equation of the convolution type in a multidimensional case. This problem is severely ill-posed. To deal with this problem, using a priori information (sourcewise representation) based on optimal recovery theory we propose a new method. The regularization and optimization properties of this method are proved. An optimal minimal a priori error of the problem is found. Moreover, a so-called optimal regularized approximate solution and its corresponding error estimation are considered. Efficiency and applicability of this method are demonstrated in a numerical example of the image deblurring problem with noisy data.


2019 ◽  
Vol 8 ◽  
Author(s):  
A. G. M. Brown ◽  
R. F. Houser ◽  
J. Mattei ◽  
A. H. Lichtenstein ◽  
S. C. Folta

Abstract Limited research considers the ethnic and cultural diversity among the US Black population, and how this diversity influences diet. The purpose of the present qualitative study is to (1) explore the influence of culture, nativity and ethnicity on the diet of US-born, African-born and Caribbean/Latin American-born Blacks and (2) explore a model of dietary acculturation among the African-born and Caribbean/Latin American-born Blacks. The purposive sample included twenty-two US-born, fifteen Caribbean/Latin American-born and ten African-born Blacks (n 47) living in Boston, who participated in either an in-depth interview (n 12) or a focus group (five groups, size 5–9). Satia-Abouta's model of dietary acculturation informed the interview and focus group questions, which explored the influence of psychosocial factors, taste preferences and environmental factors on dietary changes. NVivo 10 software was utilised for the coding and analysis. Topics based on a priori and posteriori analyses included differences in psychosocial factors and taste preferences and environmental factors by nativity. Caribbean/Latin American-born and African-born Blacks expressed the importance of cultural identity in their dietary preferences and found adaptive strategies to maintain cultural diet, while US-born Blacks demonstrated a variety of preferences for traditionally African American foods. Environmental factors varied by place of birth and residence, with US-born Blacks citing poorer quality and limited affordability of foods. These findings suggest the importance of psychosocial and environmental factors in shaping the diet of the ethnically diverse US Black population and underscore the dietary diversity within and across the different ethnic groups of Blacks.


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