Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial.
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SUBMITTER: Mecklenburg G
PROVIDER: S-EPMC5943627 | biostudies-literature | 2018 Apr
REPOSITORIES: biostudies-literature
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Effects of a 12-Week Digital Care Program for Chronic Knee Pain on Pain, Mobility, and Surgery Risk: Randomized Controlled Trial.
Mecklenburg Gabriel G Smittenaar Peter P Erhart-Hledik Jennifer C JC Perez Daniel A DA Hunter Simon S
Journal of medical Internet research 20180425 4
<h4>Background</h4>Chronic knee pain, most commonly caused by knee osteoarthritis, is a prevalent condition which in most cases can be effectively treated through conservative, non-surgical care involving exercise therapy, education, psychosocial support, and weight loss. However, most people living with chronic knee pain do not receive adequate care, leading to unnecessary use of opiates and surgical procedures.<h4>Objective</h4>Assess the efficacy of a remotely delivered digital care program f ...[more]
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Project description:Chronic knee pain (CKP) affects a large number of adults, many of whom do not receive best-practice care and are at high risk for unnecessary surgery.The aim of this study was to investigate the effect of the Hinge Health 12-week digital care program (DCP) for CKP on knee pain and function, with secondary outcomes of surgery interest and satisfaction, at 12 weeks and 6 months after starting the program.Individuals with CKP were recruited onto the 12-week program, comprising sensor-guided physical exercises, weekly education, activity tracking, and psychosocial support such as personal coaching and cognitive behavioral therapy (CBT). We used a single-arm design with assessment of outcomes at baseline, 12 weeks, and 6 months after starting the program. We used a linear mixed effects model with Tukey contrasts to compare timepoints and report intention-to-treat statistics with last observation carried forward.The cohort consisted of 41 individuals (32 female, mean age 52 years, SD 9 years). Between baseline and week 12, participants reported clinically significant improvements in the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) function scales of 16 points (95% CI 12-21, P<.001) and 10 points (95% CI 6-14, P<.001), respectively. Significant reductions of 57% (mean difference 30, 95% CI 21-38, P<.001) and 51% (mean difference 25, 95% CI 16-33, P<.001) in visual analog scale (VAS) knee pain and stiffness, respectively, were observed at 12 weeks, as well as a 67% reduction in surgery interest (mean reduction 2.3 out of 10, 95% CI 1.5-3.1, P<.001). Average satisfaction at week 12 was 9.2 out of 10. Critically, all improvements were maintained at 6 months at similar or greater magnitude.Participants on the Hinge Health DCP for CKP showed substantial clinical improvements that were maintained 6 months after enrolling in the program. This shows that DCPs carry strong potential to deliver evidence-based, cost-effective care to those suffering from CKP.
| S-EPMC5460069 | biostudies-literature
Project description:BackgroundMusculoskeletal (MSK) pain disproportionately affects people from different ethnic backgrounds through higher burden and less access to care. Digital care programs (DCPs) can improve access and help reduce inequities. However, the outcomes of such programs based on race and ethnicity have yet to be studied.ObjectiveWe aimed to assess the impact of race and ethnicity on engagement and outcomes in a multimodal DCP for MSK pain.MethodsThis was an ad hoc analysis of an ongoing decentralized single-arm investigation into engagement and clinical-related outcomes after a multimodal DCP in patients with MSK conditions. Patients were stratified by self-reported racial and ethnic group, and their engagement and outcome changes between baseline and 12 weeks were compared using latent growth curve analysis. Outcomes included program engagement (number of sessions), self-reported pain scores, likelihood of surgery, Generalized Anxiety Disorder 7-item scale, Patient Health Questionnaire 9-item, and Work Productivity and Activity Impairment. A minimum clinically important difference (MCID) of 30% was calculated for pain, and multivariable logistic regression was performed to evaluate race as an independent predictor of meeting the MCID.ResultsA total of 6949 patients completed the program: 65.5% (4554/6949) of them were non-Hispanic White, 10.8% (749/6949) were Black, 9.7% (673/6949) were Asian, 9.2% (636/6949) were Hispanic, and 4.8% (337/6949) were of other racial or ethnic backgrounds. The population studied was diverse and followed the proportions of the US population. All groups reported high engagement and satisfaction, with Hispanic and Black patients ranking first among satisfaction despite lower engagement. Black patients had a higher likelihood to drop out (odds ratio [OR] 1.19, 95% CI 1.01-1.40, P=.04) than non-Hispanic White patients. Hispanic and Black patients reported the highest level of pain, surgical intent, work productivity, and impairment in activities of daily living at baseline. All race groups showed a significant improvement in all outcomes, with Black and Hispanic patients reporting the greatest improvements in clinical outcomes. Hispanic patients also had the highest response rate for pain (75.8%) and a higher OR of meeting the pain MCID (OR 1.74, 95% CI 1.24-2.45, P=.001), when compared with non-Hispanic White patients, independent of age, BMI, sex, therapy type, education level, and employment status. No differences in mental health outcomes were found between race and ethnic groups.ConclusionsThis study advocates for the utility of a DCP in improving access to MSK care and promoting health equity. Engagement and satisfaction rates were high in all the groups. Black and Hispanic patients had higher MSK burden at baseline and lower engagement but also reported higher improvements, with Hispanic patients presenting a higher likelihood of pain improvement.
| S-EPMC9664333 | biostudies-literature
Project description:Low back pain (LBP) is the world's leading cause of years lived with disability. Digital exercise-based interventions have shown great potential in the management of musculoskeletal conditions, promoting access and easing the economic burden. However, evidence of their effectiveness for chronic LBP (CLBP) management compared to in-person physiotherapy has yet to be unequivocally established. This randomized controlled trial (RCT) aims to compare the clinical outcomes of patients with CLBP following a digital intervention versus evidence-based in-person physiotherapy. Our results demonstrate that patient satisfaction and adherence were high and similar between groups, although a significantly lower dropout rate is observed in the digital group (11/70, 15.7% versus 24/70, 34.3% in the conventional group; P = 0.019). Both groups experience significant improvements in disability (primary outcome), with no differences between groups in change from baseline (median difference: -0.55, 95% CI: -2.42 to 5.81, P = 0.412) or program-end scores (-1.05, 95% CI: -4.14 to 6.37; P = 0.671). Likewise, no significant differences between groups are found for secondary outcomes (namely pain, anxiety, depression, and overall productivity impairment). This RCT demonstrates that a remote digital intervention for CLBP can promote the same levels of recovery as evidence-based in-person physiotherapy, being a potential avenue to ease the burden of CLBP.
| S-EPMC10329005 | biostudies-literature
Project description:BackgroundCurrent guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control.ObjectiveThis study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA.MethodsThis was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index.ResultsWe enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes.ConclusionsA 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA.Trial registrationClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323.
| S-EPMC7367519 | biostudies-literature
Project description:BackgroundDigital health interventions may improve osteoarthritis (OA) management. This study evaluated the acceptability and preliminary effectiveness of a multimodal digital nutrition, exercise, and mindfulness intervention in adults with knee OA.MethodsAdults with advanced knee OA and an orthopaedic referral were invited to self-enroll in a pragmatic 12-week single-arm intervention. OA-focused nutrition and exercise resources were delivered weekly by email, and secondary components accessed on-demand (web-platform, webinars, and nutrition consultation). Acceptability was assessed by qualitative interview data and completion rates. Preliminary effectiveness on clinical outcomes was assessed by change in health-related quality of life, well-being, mindfulness, self-efficacy, and interest in total knee arthroplasty (TKA) between baseline and 12-weeks.ResultsN = 102 patients self-enrolled (73.5% female, age 64 ± 7 years, body mass index 32.9 ± 7.3 kg/m2); n = 53 completed the 12-week intervention (71.7% female, age 65 ± 7 years, body mass index 33.4 ± 6.3 kg/m2). Acceptability was demonstrated by positive perceptions of tailored intervention resources. In study completers, health-related quality of life components of pain and physical functioning domains improved at 12-weeks [change in SF36 4.4 (95%CI 0.2-8.6), p = 0.016, and 6.7 (95%CI 2.7-10.7), p < 0.001, respectively]. Self-efficacy for managing daily activities improved [change in PROMIS T-score 4.4 (95%CI 2.8-6.0), p < 0.001].ConclusionA 12-week digital multimodal intervention for knee OA was acceptable to patients and shows preliminary effectiveness in improving self-efficacy, aspects of quality of life, and decreasing interest in TKA. Digital behavioral interventions for knee OA may be an acceptable approach to improve patient outcomes and OA self-management while potentially reducing utilization of costly health system resources.
| S-EPMC9936108 | biostudies-literature
Project description:BackgroundOsteoarthritis is a leading contributor to global disability. While evidence supports the effectiveness of Tai Chi in improving symptoms for people with hip/knee osteoarthritis, access to in-person Tai Chi classes may be difficult for many people. An unsupervised online Tai Chi intervention for people with osteoarthritis can help overcome accessibility barriers. The Approach to Human-Centered, Evidence-Driven Adaptive Design (AHEAD) framework provides a practical guide for co-designing such an intervention.ObjectiveThis study aims to develop an unsupervised online Tai Chi program for people with hip/knee osteoarthritis.MethodsAn iterative process was conducted using the AHEAD framework. Initially, a panel of Tai Chi instructors and people with osteoarthritis was assembled. A literature review was conducted to inform the content of a survey (survey 1), which was completed by the panel and additional Australian Tai Chi instructors to identify Tai Chi movements for potential inclusion. Selection of Tai Chi movements was based on 3 criteria: those that were appropriate (for people with hip/knee osteoarthritis aged 45+ years), safe (to be performed at home unsupervised), and practical (to be delivered online using prerecorded videos). Movements that met these criteria were then ranked in a second survey (survey 2; using conjoint analysis methodology). Survey findings were discussed in a focus group, and the Tai Chi movements for program use were identified. A draft of the online Tai Chi program was developed, and a final survey (survey 3) was conducted with the panel to rate the appropriateness and safety of the proposed program. The final program was developed, and usability testing (think-aloud protocol) was conducted with people with knee osteoarthritis.ResultsThe panel consisted of 10 Tai Chi instructors and 3 people with osteoarthritis. The literature review identified Yang Style 24 as a common and effective Tai Chi style used in hip/knee osteoarthritis studies. Surveys 1 (n=35) and 2 (n=27) produced a ranked list of 24 Tai Chi movements for potential inclusion. This list was refined and informed by a focus group, with 10 Tai Chi movements being selected for inclusion (known as the Yang Style 10 form). Survey 3 (n=13) found that 92% (n=12) of the panel members believed that the proposed draft Tai Chi program was appropriate and safe, resulting in its adoption. The final program was produced and hosted on a customized website, "My Joint Tai Chi," which was further refined based on user feedback (n=5). "My Joint Tai Chi" is currently being evaluated in a randomized controlled trial.ConclusionsThis study demonstrates the use of the AHEAD framework to develop an unsupervised online Tai Chi intervention ("My Joint Tai Chi") for people with hip/knee osteoarthritis. This intervention is now being tested for effectiveness and safety in a randomized controlled trial.
| S-EPMC11474117 | biostudies-literature
Project description:BACKGROUND:Chronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective. OBJECTIVE:This study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain. METHODS:A longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity. RESULTS:A total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month. In total, 78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. Furthermore, the number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes. Secondary outcomes included a 57.9% and 58.3% decrease in depression and anxiety scores, respectively, and 61.5% improvement in work productivity. Finally, 3 distinct clusters of pain response trajectories were identified, which could be predicted with a mean 76% accuracy using baseline measures. CONCLUSIONS:These results support the efficacy and scalability of a DCP for chronic low back and knee pain in a large, diverse, real-world population. Participants demonstrated high completion and engagement rates and a significant positive relationship between engagement and pain reduction was identified, a finding that has not been previously demonstrated in a DCP. Furthermore, the large sample size allowed for the identification of distinct pain response subgroups, which may prove beneficial in predicting recovery and tailoring future interventions. This is the first longitudinal digital health study to analyze pain outcomes in a sample of this magnitude, and it supports the prospect for DCPs to serve the overwhelming number of musculoskeletal pain sufferers worldwide.
| S-EPMC7248800 | biostudies-literature
Project description:Chronic pain affects up to 28% of U.S. adults, costing ∼$560 billion each year. Chronic pain is an instantiation of the perennial complexity of how to best assess and treat chronic diseases over time, especially in populations where age, medical comorbidities, and socioeconomic barriers may limit access to care. Chronic disease management poses a particular challenge for the healthcare system's transition from fee-for-service to value and risk-based reimbursement models. Remote, passive real-time data from smartphones could enable more timely interventions and simultaneously manage risk and promote better patient outcomes through predicting and preventing costly adverse outcomes; however, there is limited evidence whether remote monitoring is feasible, especially in the case of older patients with chronic pain. Here, we introduce the Pain Intervention and Digital Research (Pain-IDR) Program as a pilot initiative launched in 2022 that combines outpatient clinical care and digital health research. The Pain-IDR seeks to test whether functional status can be assessed passively, through a smartphone application, in older patients with chronic pain. We discuss two perspectives-a narrative approach that describes the clinical settings and rationale behind changes to the operational design, and a quantitative approach that measures patient recruitment, patient experience, and HERMES data characteristics. Since launch, we have had 77 participants with a mean age of 55.52, of which n = 38 have fully completed the 6 months of data collection necessitated to be considered in the study, with an active data collection rate of 51% and passive data rate of 78%. We further present preliminary operational strategies that we have adopted as we have learned to adapt the Pain-IDR to a productive clinical service. Overall, the Pain-IDR has successfully engaged older patients with chronic pain and presents useful insights for others seeking to implement digital phenotyping in other chronic disease settings.
| S-EPMC10869590 | biostudies-literature
Project description:ImportanceAlthough pain is among the most common symptoms reported by patients, primary care practitioners (PCPs) face substantial challenges identifying and assessing pain.ObjectiveTo evaluate a 2-step process for chronic pain screening and follow-up in primary care.Design, setting, and participantsA cross-sectional study of patients with a primary care visit between July 2, 2018, and June 1, 2019, was conducted at a statewide, multisite federally qualified health center. Participants included 68 PCPs and 58 medical assistants from 13 sites who implemented the screening process in primary care, and 38 866 patients aged 18 years or older with a primary care visit during that time.ExposuresSingle-question assessment of pain frequency, followed by a 3-question PEG (pain, enjoyment of life, general activity) functional assessment for patients with chronic pain.Main outcomes and measuresAdherence to a 2-step chronic pain screening and PEG process, proportion of patients with positive screening results, mean PEG pain severity greater than or equal to 7, and documented chronic painful condition diagnosis in patient's electronic health record between 1 year before and 90 days after screening.ResultsOf 38 866 patients with a primary care visit, 31 600 patients (81.3%) underwent screening. Mean (SD) age was 46.2 (15.4) years, and most were aged 35 to 54 years (12 987 [41.1%]), female (18 436 [58.3%]), Hispanic (14 809 [46.9%]), and English-speaking (22 519 [71.3%]), and had Medicaid insurance (18 442 [58.4%]). A total of 10 262 participants (32.5%) screened positive and, of these, 9701 (94.5%) completed the PEG questionnaire. PEG responses indicated severe pain interference with activities of daily living (PEG ≥7) in 5735 (59.1%) participants. A chronic painful condition had not been diagnosed in 4257 (43.9%) patients in the year before screening. A new chronic painful condition was diagnosed at screening or within 90 days in 2250 (52.9%) patients. Care teams found the workflow acceptable, but cited lengthy administration time, challenges with comprehension of the PEG questions, and limited comprehensiveness as implementation barriers.Conclusions and relevanceA systematic, 2-step process for chronic pain screening and functional assessment in primary care appeared to identify patients with previously undocumented chronic pain and was feasible to implement. Patient-provided information on the frequency of pain, pain level, and pain interference can help improve the assessment and monitoring of pain in primary care.
| S-EPMC8317006 | biostudies-literature
Project description:Chronic hip pain is a cause of disability worldwide. Digital interventions (DI) may promote access while providing proper management. This single-arm interventional study assesses the clinical outcomes and engagement of a completely remote multimodal DI in patients with chronic hip pain. This home-based DI consisted of exercise (with real-time biofeedback), education, and cognitive-behavioral therapy. Outcomes were calculated between baseline and program end, using latent growth curve analysis. Primary outcome was the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes were pain, intent to undergo surgery, mental health, productivity, patient engagement (exercise sessions frequency), and satisfaction. Treatment response was assessed using a 30% pain change cut-off. A completion rate of 74.2% (396/534), alongside high patient engagement (2.9 exercise sessions/week, SD 1.1) and satisfaction (8.7/10, SD 1.6) were observed. Significant improvements were observed across all HOOS sub-scales (14.7−26.8%, p < 0.05), with 66.8% treatment responders considering pain. Marked improvements were observed in surgery intent (70.1%), mental health (54%), and productivity impairment (60.5%) (all p < 0.001). The high engagement and satisfaction reported after this DI, alongside the clinical outcome improvement, support the potential of remote care in the management of chronic hip conditions.
| S-EPMC9408636 | biostudies-literature