Fear Avoidance Beliefs in Upper-Extremity Musculoskeletal Pain Conditions: Secondary Analysis of a Prospective Clinical Study on Digital Care Programs.

BACKGROUND: Fear-avoidance beliefs (FAB) have been associated with poorer prognosis and decreased adherence to exercise-based treatments in musculoskeletal (MSK) pain. However, the impact of high FAB on adherence and outcomes in upper extremity MSK (UEMSK) pain is poorly explored, particularly through exercise-based digital care programs (DCP). OBJECTIVE: Assess the adherence levels, clinical outcomes and satisfaction in patients with UEMSK pain and elevated FAB after a fully remote multimodal DCP. Associations between FABQ-PA and clinical outcomes were conducted. METHODS: Secondary analysis of an ongoing clinical trial. Participants with UEMSK pain (shoulder, elbow, and wrist/hand) and elevated FAB-physical activity (FABQ-PA ≥ 15) were included. Adherence (completion rate, sessions/week, total exercise time) and mean change in clinical outcomes-disability (QuickDASH), numerical pain score, FABQ-PA, anxiety (GAD-7), and depression (PHQ-9)-between baseline and end-of-program were assessed. Associations between FABQ-PA and clinical outcomes were conducted. RESULTS: 520 participants were included, with mean baseline FABQ-PA of 18.02 (SD 2.77). Patients performed on average 29.3 exercise sessions (2.8 sessions/week), totalizing 338.2 exercise minutes. Mean satisfaction was 8.5/10 (SD 1.7). Significant improvements were observed in all clinical outcomes. Higher baseline FAB were associated with higher baseline disability (P < .001), and smaller improvements in disability (P < .001) and pain (P = .001). Higher engagement was associated with greater improvements in FABQ-PA (P = .043) and pain (P = 0.009). CONCLUSIONS: This study provides evidence of the potential benefits of a structured and multimodal home-based DCP in the management of UEMSK pain conditions in patients with elevated FAB in a real-world context.

Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial.

BACKGROUND: Chronic shoulder pain (CSP) is a common condition with various etiologies, including rotator cuff disorders, adhesive capsulitis, shoulder instability, and shoulder arthritis. It is associated with substantial disability and psychological distress, resulting in poor productivity and quality of life. Physical therapy constitutes the mainstay treatment for CSP, but several barriers exist in accessing care. In recent years, telerehabilitation has gained momentum as a potential solution to overcome such barriers. It has shown numerous benefits, including improving access and convenience, promoting patient adherence, and reducing costs. However, to date, no previous randomized controlled trial has compared fully remote digital physical therapy to in-person rehabilitation for nonoperative CSP. OBJECTIVE: The aim of this study is to compare clinical outcomes between digital physical therapy and conventional in-person physical therapy in patients with CSP. METHODS: We conducted a single-center, parallel-group, randomized controlled trial involving 82 patients with CSP referred for outpatient physical therapy. Participants were randomized into digital or conventional physical therapy (8-week interventions). The digital intervention consisted of home exercise, education, and cognitive behavioral therapy (CBT), using a device with movement digitalization for biofeedback and asynchronous physical therapist monitoring through a cloud-based portal. The conventional group received in-person physical therapy, including exercises, manual therapy, education, and CBT. The primary outcome was the change (baseline to 8 weeks) in function and symptoms using the short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcome measures included self-reported pain, surgery intent, analgesic intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically. RESULTS: A total of 90 participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function measured by the short-form of the Disabilities of the Arm, Shoulder, and Hand questionnaire, with no differences between groups (-1.8, 95% CI -13.5 to 9.8; P=.75). For secondary outcomes, no differences were observed in surgery intent, analgesic intake, and mental health or worst pain. Higher reductions were observed in average and least pain in the conventional group, which, given the small effect sizes (least pain 0.15 and average pain 0.16), are unlikely to be clinically meaningful. High adherence and satisfaction were observed in both groups, with no adverse events. CONCLUSIONS: This study shows that fully remote digital programs can be viable care delivery models for CSP given their scalability and effectiveness, assessed through comparison with high-dosage in-person rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04636528); https://clinicaltrials.gov/study/NCT04636528.

Telerehabilitation of acute musculoskeletal multi-disorders: prospective, single-arm, interventional study.

BACKGROUND: Acute musculoskeletal (MSK) pain is very common and associated with impaired productivity and high economic burden. Access to timely and personalized, evidence-based care is key to improve outcomes while reducing healthcare expenditure. Digital interventions can facilitate access and ensure care scalability. OBJECTIVE: Present the feasibility and results of a fully remote digital care program (DCP) for acute MSK conditions affecting several body areas. METHODS: Interventional single-arm study of individuals applying for digital care programs for acute MSK pain. Primary outcome was the mean change between baseline and end-of-program in self-reported Numerical Pain Rating Scale (NPRS) score and secondary outcomes were change in analgesic consumption, intention to undergo surgery, anxiety (GAD-7), depression (PHQ-9), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI-GH) and engagement. RESULTS: Three hundred forty-three patients started the program, of which 300 (87.5%) completed the program. Latent growth curve analysis (LGCA) revealed that changes in NPRS between baseline and end-of-program were both statistically (p < 0.001) and clinically significant: 64.3% reduction (mean - 2.9 points). Marked improvements were also noted in all secondary outcomes: 82% reduction in medication intake, 63% reduction in surgery intent, 40% in fear-avoidance beliefs, 54% in anxiety, 58% in depression and 79% recovery in overall productivity. All outcomes had steeper improvements in the first 4 weeks, which paralleled higher engagement in this period (3.6 vs 3.2 overall weekly sessions, p < 0.001). Mean patient satisfaction score was 8.7/10 (SD 1.26). STRENGTHS AND LIMITATIONS: This is the first longitudinal study demonstrating the feasibility of a DCP for patients with acute MSK conditions involving several body areas. Major strengths of this study are the large sample size, the wide range of MSK conditions studied, the breadth of outcomes measured, and the very high retention rate and adherence level. The major limitation regards to the absence of a control group. CONCLUSIONS: We observed very high completion and engagement rates, as well as clinically relevant changes in all health-related outcomes and productivity recovery. We believe this DCP holds great potential in the delivery of effective and scalable MSK care. TRIAL REGISTRATION: NCT, NCT04092946 . Registered 17/09/2019.

Impacts of Digital Care Programs for Musculoskeletal Conditions on Depression and Work Productivity: Longitudinal Cohort Study.

BACKGROUND: Comorbidity between musculoskeletal (MSK) pain and depression is highly common, and is associated with a greater symptom burden and greater loss of work productivity than either condition alone. Multimodal care programs tackling both physical and mental health components may maximize productivity recovery and return to work. Digital delivery of such programs can facilitate access, ensure continuity of care, and enhance patient engagement. OBJECTIVE: The aim of this study was to assess the impact of a completely remote multimodal digital care program (DCP) for MSK pain on mental health and work-related outcomes stratified by baseline depression levels. METHODS: Ad hoc analysis of an interventional, single-arm, cohort study of individuals with MSK pain undergoing a DCP was performed. Three subgroups with different baseline depression severity levels were established based on responses to the Patient Health Questionnaire (PHQ-9): cluster 1 (score<5: minimal depression), cluster 2 (scores 5-10: mild depression), and cluster 3 (score≥10: moderate depression). The mean changes in depression, anxiety, fear-avoidance beliefs, work productivity, and activity impairment and adherence between baseline and end of program (8-12 weeks) were assessed across subgroups by latent growth curve analysis. RESULTS: From a total of 7785 eligible participants, 6137 (78.83%) were included in cluster 1, 1158 (14.87%) in cluster 2, and 490 (6.29%) in cluster 3. Significant improvements in depression and anxiety scores were observed in clusters 2 and 3 but not in cluster 1, with average end-of-the program scores in clusters 2 and 3 below the initially defined cluster thresholds (score of 5 and 10, respectively). All clusters reported significant improvements in productivity impairment scores (mean changes from -16.82, 95% CI -20.32 to -13.42 in cluster 1 to -20.10, 95% CI -32.64 to -7.57 in cluster 3). Higher adherence was associated with higher improvements in depression in clusters 2 and 3, and with greater recovery in activities of daily living in cluster 3. Overall patient satisfaction was 8.59/10.0 (SD 1.74). CONCLUSIONS: A multimodal DCP was able to promote improvements in productivity impairment scores comparable to those previously reported in the literature, even in participants with comorbid depression and anxiety. These results reinforce the need to follow a biopsychosocial framework to optimize outcomes in patients with MSK pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04092946; https://clinicaltrials.gov/ct2/show/NCT04092946.

Racial and Ethnic Differences in Outcomes of a 12-Week Digital Rehabilitation Program for Musculoskeletal Pain: Prospective Longitudinal Cohort Study.

BACKGROUND: Musculoskeletal (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. OBJECTIVE: We aimed to assess the impact of race and ethnicity on engagement and outcomes in a multimodal DCP for MSK pain. METHODS: This 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. RESULTS: A 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. CONCLUSIONS: This 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.

Modulation of the In Vivo Inflammatory Response by Pro- Versus Anti-Inflammatory Intervertebral Disc Treatments.

Inflammation is central in intervertebral disc (IVD) degeneration/regeneration mechanisms, and its balance is crucial to maintain tissue homeostasis. This work investigates the modulation of local and systemic inflammatory response associated with IVD degeneration/herniation by administration of PRO- versus ANTI-inflammatory treatments. Chitosan/poly-γ-glutamic acid nanocomplexes, known as pro-inflammatory (PRO), and soluble diclofenac, a non-steroidal anti-inflammatory drug (ANTI), were intradiscally administered in a rat IVD injury model, 24 h after lesion. Two weeks after administration, a reduction of disc height accompanied by hernia formation was observed. In the PRO-inflammatory treated group, IL-1ß, IL-6 and COX-2 IVD gene expression were upregulated, and loss of nucleus pulposus (NP) structure and composition was observed. Systemically, lower T-cell frequency was observed in the lymph nodes (LN) and spleen (SP) of the PRO group, together with an increase in CD4+ T cells subset in the blood (BL) and LN. In contrast, the ANTI-group had higher proteoglycans/collagen ratio and collagen type 2 content in the NP, while an increase in the frequency of myeloid cells, M1 macrophages and activated macrophages (MHCII+) was observed at the systemic level. Overall, this study illustrates the dynamics of local and systemic inflammatory and immune cell responses associated with intradiscal therapies, which will contribute to designing more successful immunomodulatory treatments for IVD degeneration.

Digital Care Program for Urinary Incontinence in Females: A Large-Scale, Prospective, Cohort Study.

Female urinary incontinence (UI) is highly prevalent in the US (>60%). Pelvic floor muscle training (PFMT) represents first-line care for UI; however, access and adherence challenges urge new care delivery models. This prospective cohort study investigates the feasibility and safety of a remote digital care program (DCP) combining education and PFMT with real-time biofeedback with an average duration of 10 weeks. The primary outcome was the change in the Urinary Impact Questionnaire-short form (UIQ-7) from baseline to program-end, calculated through latent growth curve analysis (LGCA). Secondary outcomes included the impact of pelvic conditions (PFIQ-7), depression (PHQ-9), anxiety (GAD-7), productivity impairment (WPAI), intention to seek additional healthcare, engagement, and satisfaction. Of the 326 participants who started the program, 264 (81.0%) completed the intervention. Significant improvement on UIQ-7 (8.8, 95%CI 4.7; 12.9, p < 0.001) was observed, corresponding to a response rate of 57.3%, together with improvements in all other outcomes and high satisfaction (8.9/10, SD 1.8). This study shows the feasibility and safety of a completely remote DCP with biofeedback managed asynchronously by a physical therapist to reduce UI-related symptoms in a real-world setting. Together, these findings may advocate for the exploration of this care delivery option to escalate access to proper and timely UI care.

Alterations of bovine nucleus pulposus cells with aging.

Aging is one of the major etiological factors driving intervertebral disc (IVD) degeneration, the main cause of low back pain. The nucleus pulposus (NP) includes a heterogeneous cell population, which is still poorly characterized. Here, we aimed to uncover main alterations in NP cells with aging. For that, bovine coccygeal discs from young (12 months) and old (10-16 years old) animals were dissected and primary NP cells were isolated. Gene expression and proteomics of fresh NP cells were performed. NP cells were labelled with propidium iodide and analysed by flow cytometry for the expression of CD29, CD44, CD45, CD146, GD2, Tie2, CD34 and Stro-1. Morphological cell features were also dissected by imaging flow cytometry. Elder NP cells (up-regulated bIL-6 and bMMP1 gene expression) presented lower percentages of CD29+, CD44+, CD45+ and Tie2+ cells compared with young NP cells (upregulated bIL-8, bCOL2A1 and bACAN gene expression), while GD2, CD146, Stro-1 and CD34 expression were maintained with age. NP cellulome showed an upregulation of proteins related to endoplasmic reticulum (ER) and melanosome independently of age, whereas proteins upregulated in elder NP cells were also associated with glycosylation and disulfide bonds. Flow cytometry analysis of NP cells disclosed the existence of 4 subpopulations with distinct auto-fluorescence and size with different dynamics along aging. Regarding cell morphology, aging increases NP cell area, diameter and vesicles. These results contribute to a better understanding of NP cells aging and highlighting potential anti-aging targets that can help to mitigate age-related disc disease.

Engagement and Utilization of a Complete Remote Digital Care Program for Musculoskeletal Pain Management in Urban and Rural Areas Across the United States: Longitudinal Cohort Study.

BACKGROUND: Musculoskeletal (MSK) conditions are the number one cause of disability worldwide. Digital care programs (DCPs) for MSK pain management have arisen as alternative care delivery models to circumvent challenges in accessibility of conventional therapy. Despite the potential of DCPs to reduce inequities in accessing care, the outcomes of such interventions in rural and urban populations have yet to be studied. OBJECTIVE: The aim of this study was to assess the impact of urban or rural residency on engagement and clinical outcomes after a multimodal DCP for MSK pain. METHODS: This study consists of an ad hoc analysis of a decentralized single-arm investigation into engagement and clinical-related outcomes after a multimodal DCP in patients with MSK conditions. Patients were coded according to their zip codes to a specific rural-urban commuting area code and grouped into rural and urban cohorts. Changes in their engagement and clinical outcomes from baseline to program end were assessed. Latent growth curve analysis was performed to estimate change trajectories adjusting for the following covariates: age, gender, BMI, employment status, and pain acuity. Outcomes included engagement, self-reported pain, and the results of the Generalized Anxiety Disorder 7-item, Patient Health Questionnaire 9-item, and Work Productivity and Activity Impairment scales. A minimum clinically important difference (MCID) of 30% was considered for pain. RESULTS: Patients with urban and rural residency across the United States participated in the program (n=9992). A 73.8% (7378/9992) completion rate was observed. Both groups reported high satisfaction scores and similar engagement with exercise sessions, with rural residents showing higher engagement with educational content (P<.001) and higher program completion rates (P=.02). All groups showed a significant improvement in all clinical outcomes, including pain, mental health, and work productivity, without statistically significant intergroup differences. The percentage of patients meeting the MCID was similar in both groups (urban: 67.1%, rural: 68.3%; P=.30). CONCLUSIONS: This study advocates for the utility of a DCP in improving access to MSK care in urban and rural areas alike, showcasing its potential to promote health equity. High engagement, satisfaction, and completion rates were noted in both groups, as well as significant improvements in clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04092946; https://clinicaltrials.gov/ct2/show/NCT04092946.

Sleep Disturbance in Musculoskeletal Conditions: Impact of a Digital Care Program.

Background: Musculoskeletal (MSK) pain is highly prevalent worldwide, resulting in significant disability, and comorbid sleep disturbances. Digital therapy for MSK pain can provide significant improvements in care access, alongside pain and disability reductions. However, studies on the effect of such programs on sleep are lacking. Purpose: To evaluate the impact on pain-related sleep impairment after a 12-week remote multimodal digital care program (DCP) for MSK conditions. Patients and Methods: This is an ad-hoc analysis of a decentralized single-arm study into engagement and clinical outcomes after a DCP for MSK rehabilitation. Patients were stratified by baseline sleep disturbance, based on sleep questions in the questionnaires: Oswestry Disability Index, Neck Disability Index, and the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Additional outcomes were pain, Generalized Anxiety Disorder 7-item scale, Patient Health 9-item questionnaire, Work Productivity, and Activity Impairment, and program engagement. Results: At baseline, 5749 patients reported sleep disturbance (78.0% of eligible patients). These reported significantly worse clinical outcomes at baseline than patients without sleep disturbance (all p<0.001). Patients with comorbid sleep disturbance showed improvements in sleep, with a significant proportion reporting full recovery at program completion: 56% of patients with upper limb conditions (including 10% of patients with severe sleep disturbance at baseline), and 24% with spine conditions. These patients also reported significant improvements in all clinical outcomes at program completion. Engagement and satisfaction were high, and also higher than in patients without sleep impairment. Conclusion: This is the first study of its kind investigating the effect of a completely remote DCP for MSK pain on sleep. Patients reporting comorbid sleep disturbance had significant improvement in sleep, alongside pain, mental health and work productivity at program completion. The results suggest that a DCP for MSK pain can improve sleep disturbances in patients with upper limb and spine conditions.

Managing Musculoskeletal Pain in Older Adults Through a Digital Care Solution: Secondary Analysis of a Prospective Clinical Study.

BACKGROUND: Aging is closely associated with an increased prevalence of musculoskeletal conditions. Digital musculoskeletal care interventions emerged to deliver timely and proper rehabilitation; however, older adults frequently face specific barriers and concerns with digital care programs (DCPs). OBJECTIVE: This study aims to investigate whether known barriers and concerns of older adults impacted their participation in or engagement with a DCP or the observed clinical outcomes in comparison with younger individuals. METHODS: We conducted a secondary analysis of a single-arm investigation assessing the recovery of patients with musculoskeletal conditions following a DCP for up to 12 weeks. Patients were categorized according to age: ≤44 years old (young adults), 45-64 years old (middle-aged adults), and ≥65 years old (older adults). DCP access and engagement were evaluated by assessing starting proportions, completion rates, ability to perform exercises autonomously, assistance requests, communication with their physical therapist, and program satisfaction. Clinical outcomes included change between baseline and program end for pain (including response rate to a minimal clinically important difference of 30%), analgesic usage, mental health, work productivity, and non-work-related activity impairment. RESULTS: Of 16,229 patients, 12,082 started the program: 38.3% (n=4629) were young adults, 55.7% (n=6726) were middle-aged adults, and 6% (n=727) were older adults. Older patients were more likely to start the intervention and to complete the program compared to young adults (odds ratio [OR] 1.72, 95% CI 1.45-2.06; P<.001 and OR 2.40, 95% CI 1.97-2.92; P<.001, respectively) and middle-aged adults (OR 1.22, 95% CI 1.03-1.45; P=.03 and OR 1.38, 95% CI 1.14-1.68; P=.001, respectively). Whereas older patients requested more technical assistance and exhibited a slower learning curve in exercise performance, their engagement was higher, as reflected by higher adherence to both exercise and education pieces. Older patients interacted more with the physical therapist (mean 12.6, SD 18.4 vs mean 10.7, SD 14.7 of young adults) and showed higher satisfaction scores (mean 8.7, SD 1.9). Significant improvements were observed in all clinical outcomes and were similar between groups, including pain response rates (young adults: 949/1516, 62.6%; middle-aged adults: 1848/2834, 65.2%; and older adults: 241/387, 62.3%; P=.17). CONCLUSIONS: Older adults showed high adherence, engagement, and satisfaction with the DCP, which were greater than in their younger counterparts, together with significant clinical improvements in all studied outcomes. This suggests DCPs can successfully address and overcome some of the barriers surrounding the participation and adequacy of digital models in the older adult population.

Randomized-controlled trial assessing a digital care program versus conventional physiotherapy for chronic low back pain.

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.

Impact on productivity impairment of a digital care program for chronic low back pain: A prospective longitudinal cohort study.

BACKGROUND: Low back pain (LBP) is the leading cause of disability in the United States and the main reason for absenteeism. Successful management of chronic LBP (CLBP) is dependent on multimodal evidence-based interventions. Digital interventions (DI) may ease accessibility to such treatments, increasing adherence, while reducing healthcare-related costs. OBJECTIVES: Assess the impact of a completely remote multimodal DI on productivity impairment in a real-work context cohort of patients with CLBP. DESIGN: Longitudinal study. METHODS: Ad-hoc analysis of an interventional, single-arm study of individuals with CLBP undergoing a DI for 12 weeks. Outcomes included the mean change in work productivity and activity impairment (including overall and non-work related activities), pain, depression, anxiety, fear-avoidance beliefs, analgesic usage, and engagement. Minimal clinically important change (MCIC) was calculated for productivity using anchor- and distribution-based methods. RESULTS: From 560 patients at program start, 78.4% completed the DI. A significant improvement in overall productivity (20.21, 95%CI: 16.48-23.94) and in non-work related activities (21.36, 95%CI: 17.49-25.22) was observed, corresponding to a responder rate of 57.1-83.3% and 60.5-79.8%, respectively, and depending on the MCIC method. Significant improvements were reported for pain (2.32 points, 95%CI: 2.02-2.61), anxiety (5.24, 95%CI: 4.18-6.29), depression (6.38, 95%CI: 4.78-7.98) and fear-avoidance beliefs (8.11, 95%CI: 6.20-10.02). Both engagement (sessions per week) and patient satisfaction scores were high, 2.9 (SD 1.0) and 8.8/10 (SD 1.6), respectively. CONCLUSIONS: This study demonstrated the utility of a multimodal DI to address productivity impairment. DIs have great potential to ease the burden of CLBP, providing an accessible and cost-effective modality of care. TRIAL REGISTRATION: The study was approved by the New England IRB (protocol number 120190313) and prospectively registered in ClinicalTrials.gov, NCT04092946, on September 17th, 2019.

Effectiveness of biofeedback-assisted asynchronous telerehabilitation in musculoskeletal care: A systematic review.

Background: Musculoskeletal conditions are the leading cause of disability worldwide. Telerehabilitation may be a viable option in the management of these conditions, facilitating access and patient adherence. Nevertheless, the impact of biofeedback-assisted asynchronous telerehabilitation remains unknown. Objective: To systematically review and assess the effectiveness of exercise-based asynchronous biofeedback-assisted telerehabilitation on pain and function in individuals with musculoskeletal conditions. Methods: This systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The search was conducted using three databases: PubMed, Scopus, and PEDro. Study criteria included articles written in English and published from January 2017 to August 2022, reporting interventional trials evaluating exercise-based asynchronous telerehabilitation using biofeedback in adults with musculoskeletal disorders. The risks of bias and certainty of evidence were appraised using the Cochrane tool and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE), respectively. The results are narratively summarized, and the effect sizes of the main outcomes were calculated. Results: Fourteen trials were included: 10 using motion tracker technology (N = 1284) and four with camera-based biofeedback (N = 467). Telerehabilitation with motion trackers yields at least similar improvements in pain and function in people with musculoskeletal conditions (effect sizes: 0.19-1.45; low certainty of evidence). Uncertain evidence exists for the effectiveness of camera-based telerehabilitation (effect sizes: 0.11-0.13; very low evidence). No study found superior results in a control group. Conclusions: Asynchronous telerehabilitation may be an option in the management of musculoskeletal conditions. Considering its potential for scalability and access democratization, additional high-quality research is needed to address long-term outcomes, comparativeness, and cost-effectiveness and identify treatment responders.

The potential of a multimodal digital care program in addressing healthcare inequities in musculoskeletal pain management.

Digital interventions have emerged as a solution for time and geographical barriers, however, their potential to target other social determinants of health is largely unexplored. In this post-hoc analysis, we report the impact of social deprivation on engagement and clinical outcomes after a completely remote multimodal musculoskeletal (MSK) digital care program managed by a culturally-sensitive clinical team. Patients were stratified in five categories according to their social deprivation index, and cross-referenced with their race/ethnicity, rurality and distance to healthcare facilities. From a total of 12,062 patients from all U.S. states, 8569 completed the program. Higher social deprivation was associated with greater baseline disease burden. We observed that all categories reported pain improvements (ranging from -2.0 95%CI -2.1, -1.9 to -2.1 95%CI -2.3, -1.9, p < 0.001) without intergroup differences in mean changes or responder rates (from 59.9% (420/701) to 66.6% (780/1172), p = 0.067), alongside reduction in analgesic consumption. We observed significant improvements in mental health and productivity across all categories, with productivity and non-work-related functional recovery being greater within the most deprived group. Engagement was high but varied slightly across categories. Together these findings highlight the importance of a patient-centered digital care program as a tool to address health inequities in musculoskeletal pain management. The idea of investigating social deprivation within a digital program provides a foundation for future work in this field to identify areas of improvement.

Intensive Rehabilitation Program in Older Adults with Stroke: Therapy Content and Feasibility-Preliminary Results from the BRAIN-CONNECTS Study.

The main objective was to assess the feasibility of an intensive rehabilitation program (IRP) for stroke patients; and secondly, to detect eventual age-related differences in content, duration, tolerability, and safety in a prospective observational cohort of patients diagnosed with subacute stroke, admitted to inpatient rehabilitation (BRAIN-CONNECTS project). Activities during physical, occupational and speech therapy, and time dedicated to each one were recorded. Forty-five subjects (63.0 years, 77.8% men) were included. The mean time of therapy was 173.8 (SD 31.5) minutes per day. The only age-related differences when comparing patients ≥65 and <65 years were a shorter time allocated for occupational therapy (-7.5 min (95% CI -12.5 to -2.6), p = 0.004) and a greater need of speech therapy (90% vs. 44%) in the older adults. Gait training, movement patterns of upper limbs, and lingual praxis were the most commonly performed activities. Regarding tolerability and safety, there were no losses to follow-up, and the attendance ratio was above 95%. No adverse events occurred during any session in all patients. Conclusion: IRP is a feasible intervention in patients with subacute stroke, regardless of age, and there are no relevant differences on content or duration of therapy.

Development of a hybrid dextrin hydrogel encapsulating dextrin nanogel as protein delivery system.

Dextrin, a glucose polymer with low molecular weight, was used to develop a fully resorbable hydrogel, without using chemical initiators. Dextrin was first oxidized (oDex) with sodium periodate and then cross-linked with adipic acid dihidrazide, a nontoxic cross-linking molecule. Furthermore, a new bidimensional composite hydrogel, made of oxidized dextrin incorporating dextrin nanogels (oDex-nanogel), was also developed. The oDex hydrogels showed good mechanical properties and biocompatibility, allowing the proliferation of mouse embryo fibroblasts 3T3 cultured on top of the gel. The gelation time may be controlled selecting the concentrations of the polymer and reticulating agent. Both the oDex and oDex-nanogel hydrogels are biodegradable and present a 3-D network with a continuous porous structure. The obtained hybrid hydrogel enables the release of the dextrin nanogel over an extended period of time, paralleling the mass loss curve due to the degradation of the material. The dextrin nanogel allowed the efficient incorporation of interleukin-10 and insulin in the oDex hydrogel, providing a sophisticated system of controlled release. The new hydrogels present promising properties as an injectable carrier of bioactive molecules. Both proteins and poorly water-soluble low-molecular-weight drugs are efficiently encapsulated in the nanogel, which performs as a controlled release system entrapped in the hydrogel matrix.

Digital Rehabilitation for Acute Low Back Pain: A Prospective Longitudinal Cohort Study.

Background: Low back pain (LBP) has a lifetime prevalence of 70-80%. Access to timely and personalized, evidence-based care is key to prevent chronic progression. Digital solutions may ease accessibility to treatment while reducing healthcare-related costs. Purpose: We aim to report the results of a fully remote digital care program (DCP) for acute LBP. Patients and Methods: This was an interventional, single-arm, cohort study of patients with acute LBP who received a DCP. Primary outcome was the mean change in disability (Oswestry Disability Index - ODI) after 12 weeks. Secondary outcomes included change in pain (NPRS), analgesic consumption, surgery likelihood, depression (PHQ-9), anxiety (GAD-7), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI) and engagement. Results: A total of 406 patients were enrolled in the program and of those, 332 (81.8%) completed the intervention. A significant disability reduction of 55.1% (14.93, 95% CI 13.95; 15.91) was observed, corresponding to a 76.1% responder rate (30% cut-off). Disability reduction was accompanied by significant improvements in pain (61.0%), depression (55.4%), anxiety (59.5%), productivity (65.6%), fear-avoidance beliefs (46.3%), intent to pursue surgery (59.1%), and analgesic consumption (from 35.7% at baseline to 10.8% at program end). DCP-related patient satisfaction score was 8.7/10.0 (SD 1.4). Conclusion: This study demonstrated the utility of a multimodal DCP for patients with acute LBP. Very high adherence rates and patient satisfaction were observed, alongside significant reductions in all assessed outcomes, consistent with the growing body of evidence supporting the management of acute LBP with DCPs.

Asynchronous and Tailored Digital Rehabilitation of Chronic Shoulder Pain: A Prospective Longitudinal Cohort Study.

BACKGROUND: Chronic shoulder pain (SP) is responsible for significant morbidity, decreased quality of life and impaired work ability, resulting in high socioeconomic burden. Successful SP management is dependent on adherence and compliance with effective evidence-based interventions. Digital solutions may improve accessibility to such treatments, increasing convenience, while reducing healthcare-related costs. PURPOSE: Present the results of a fully remote digital care program (DCP) for chronic SP. PATIENTS AND METHODS: Interventional, single-arm, cohort study of individuals with chronic SP applying for a digital care program. Primary outcome was the mean change between baseline and 12 weeks on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Secondary outcomes were change in pain (NPRS), analgesic consumption, intention to undergo surgery, anxiety (GAD-7), depression (PHQ-9), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI) and engagement. RESULTS: From 296 patients at program start, 234 (79.1%) completed the intervention. Changes in QuickDASH between baseline and end-of-program were both statistically (p < 0.001) and clinically significant, with a mean reduction of 51.6% (mean -13.45 points, 95% CI: 11.99; 14.92). Marked reductions were also observed in all secondary outcomes: 54.8% in NPRS, 44.1% ceased analgesics consumption, 55.5% in surgery intent, 37.7% in FABQ-PA, 50.3% in anxiety, 63.6% in depression and 66.5% in WPAI overall. Higher engagement was associated with higher improvements in disability. Mean patient satisfaction score was 8.7/10.0 (SD 1.6). CONCLUSION: This is the first real-world cohort study reporting the results of a multimodal remote digital approach for chronic SP rehabilitation. High completion and engagement rates were observed, which were associated with clinically significant improvement in all health-related outcomes, as well as marked productivity recovery. These promising results support the potential of digital modalities to address the global burden of chronic musculoskeletal pain.

Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate the clinical impact of a 12-wk home-based digitally assisted rehabilitation program after arthroscopic rotator cuff repair against conventional home-based rehabilitation. DESIGN: The digital therapy group performed independent technology-assisted sessions complemented with 13 face-to-face sessions, and the conventional therapy group had conventional face-to-face physical therapy (30 sessions). Primary outcome was functional change between baseline and 12 wks, measured through the Constant-Murley score. Secondary outcomes were the change in the QuickDASH Scale and shoulder range of motion. RESULTS: Fifty participants enrolled; 41 completed the 12-wk program (23 digital therapy group vs. 18 conventional therapy group), and 32 (15 vs. 17) were available for the 12-mo follow-up assessment. No differences were found between groups regarding study endpoints at the end of the 12-wk program. However, follow-up results revealed the superiority of the digital therapy group for QuickDASH (P = 0.043), as well as an interaction between time and group in the Constant-Murley score (P = 0.047) in favor of the digital therapy group. CONCLUSIONS: The results demonstrate that digital therapeutics can be used to achieve similar, if not superior, short- and long-term outcomes as conventional approaches after arthroscopic rotator cuff repair, while being far less human resource intensive than conventional care.Level of evidence: II.