Virtual Reality for Sub-Acute Pain After Orthopedic Traumatic Musculoskeletal Injuries: A Mixed Methods Pilot Study.

OBJECTIVES: Acute orthopedic traumatic musculoskeletal injuries are prevalent, costly, and often lead to persistent pain and functional limitations. Psychological risk factors (pain catastrophizing and anxiety) exacerbate these outcomes but are often overlooked in acute orthopedic care. Addressing gaps in current treatment approaches, this mixed methods pilot study explored the use of a therapeutic virtual reality (VR; RelieVRx), integrating mindfulness and cognitive behavioral therapy, for pain self-management at home following orthopedic injury. METHODS: We enrolled 10 adults with recent orthopedic injuries and elevated pain catastrophizing or pain anxiety from Level 1 Trauma Clinics within the Mass General Brigham healthcare system. Participants completed daily RelieVRx sessions at home for 8 weeks, which included pain education, relaxation, mindfulness, games, and dynamic breathing biofeedback. Primary outcomes were a-priori feasibility, appropriateness, acceptability, satisfaction, and safety. Secondary outcomes were pre-post measures of pain, physical function, sleep, depression, and mechanisms (pain self-efficacy, mindfulness, and coping). RESULTS: The VR and study procedures met or exceeded all benchmarks. We observed preliminary improvements in pain, physical functioning, sleep, depression, and mechanisms. Qualitative exit interviews confirmed high satisfaction with RelieVRx and yielded recommendations for promoting VR-based trials with orthopedic patients. DISCUSSION: The results support a larger randomized clinical trial of RelieVRx versus a sham placebo control to replicate the findings and explore mechanisms. There is potential for self-guided VR to promote evidence-based pain management strategies and address the critical mental health care gap for patients following acute orthopedic injuries.

A Brief Mind-body Intervention Is Feasible and May Prevent Persistent Pain After Acute Orthopaedic Traumas: A Randomized Controlled Trial.

BACKGROUND: Approximately 20% to 50% of patients develop persistent pain after traumatic orthopaedic injuries. Psychosocial factors are an important predictor of persistent pain; however, there are no evidence-based, mind-body interventions to prevent persistent pain for this patient population. QUESTIONS/PURPOSES: (1) Does the Toolkit for Optimal Recovery after Injury (TOR) achieve a priori feasibility benchmarks in a multisite randomized control trial (RCT)? (2) Does TOR demonstrate a preliminary effect in improving pain, as well as physical and emotional function? METHODS: This pilot RCT of TOR versus a minimally enhanced usual care comparison group (MEUC) was conducted among 195 adults with an acute orthopaedic traumatic injury at risk for persistent pain at four geographically diverse Level 1 trauma centers between October 2021 to August 2023. Fifty percent (97 of 195) of participants were randomized to TOR (mean age 43 ± 17 years; 67% [65 of 97] women) and 50% (98) to MEUC (mean age 45 ± 16 years; 67% [66 of 98] women). In TOR, 24% (23 of 97) of patients were lost to follow-up, whereas in the MEUC, 17% (17 of 98) were lost. At 4 weeks, 78% (76 of 97) of patients in TOR and 95% (93 of 98) in the MEUC completed the assessments; by 12 weeks, 76% (74 of 97) of patients in TOR and 83% (81 of 98) in the MEUC completed the assessments (all participants were still included in the analysis consistent with an intention-to-treat approach). The TOR has four weekly video-administered sessions that teach pain coping skills. The MEUC is an educational pamphlet. Both were delivered in addition to usual care. Primary outcomes were feasibility of recruitment (the percentage of patients who met study criteria and enrolled) and data collection, appropriateness of treatment (the percent of participants in TOR who score above the midpoint on the Credibility and Expectancy Scale), acceptability (the percentage of patients in TOR who attend at least three of four sessions), and treatment satisfaction (the percent of participants in TOR who score above the midpoint on the Client Satisfaction Scale). Secondary outcomes included additional feasibility (including collecting data on narcotics and rescue medications and adverse events), fidelity (whether the intervention was delivered as planned) and acceptability metrics (patients and staff), pain (numeric rating scale), physical function (Short Musculoskeletal Function Assessment questionnaire [SMFA], PROMIS), emotional function (PTSD [PTSD Checklist], depression [Center for Epidemiologic Study of Depression]), and intervention targets (pain catastrophizing, pain anxiety, coping, and mindfulness). Assessments occurred at baseline, 4 and 12 weeks. RESULTS: Several outcomes exceeded a priori benchmarks: feasibility of recruitment (89% [210 of 235] of eligible participants consented), appropriateness (TOR: 73% [66 of 90] scored > midpoint on the Credibility and Expectancy Scale), data collection (79% [154 of 195] completed all surveys), satisfaction (TOR: 99% [75 of 76] > midpoint on the Client Satisfaction Scale), and acceptability (TOR: 73% [71 of 97] attended all four sessions). Participation in TOR, compared with the MEUC, was associated with improvement from baseline to postintervention and from baseline to follow-up in physical function (SMFA, baseline to post: -7 [95% CI -11 to -4]; p < 0.001; baseline to follow-up: -6 [95% CI -11 to -1]; p = 0.02), PROMIS (PROMIS-PF, baseline to follow-up: 2 [95% CI 0 to 4]; p = 0.045), pain at rest (baseline to post: -1.2 [95% CI -1.7 to -0.6]; p < 0.001; baseline to follow-up: -1 [95% CI -1.7 to -0.3]; p = 0.003), activity (baseline to post: -0.7 [95% CI -1.3 to -0.1]; p = 0.03; baseline to follow-up: -0.8 [95% CI -1.6 to -0.1]; p = 0.04), depressive symptoms (baseline to post: -6 [95% CI -9 to -3]; p < 0.001; baseline to follow-up: -5 [95% CI -9 to -2]; p < 0.002), and posttraumatic symptoms (baseline to post: -4 [95% CI -7 to 0]; p = 0.03; baseline to follow-up: -5 [95% CI -9 to -1]; p = 0.01). Improvements were generally clinically important and sustained or continued through the 3 months of follow-up (that is, above the minimum clinically important different [MCID] of 7 for the SMFA, the MCID of 3.6 for PROMIS, the MCID of 2 for pain at rest and pain during activity, the MCID of more than 10% change in depressive symptoms, and the MCID of 10 for posttraumatic symptoms). There were treatment-dependent improvements in pain catastrophizing, pain anxiety, coping, and mindfulness. CONCLUSION: TOR was feasible and potentially efficacious in preventing persistent pain among patients with an acute orthopaedic traumatic injury. Using TOR in clinical practice may prevent persistent pain after orthopaedic traumatic injury. LEVEL OF EVIDENCE: Level I, therapeutic study.

Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

BACKGROUND: Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. METHODS: Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings. RESULTS: The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest. CONCLUSIONS: This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. CLINICAL TRIAL REGISTRATION: NCT05700383.

Exploring mechanisms of improvement in the Active Brains intervention for older adults with chronic pain and early cognitive decline.

OBJECTIVES: We iteratively developed, optimized, and established the feasibility of a virtual, group-based, mind-body activity program (Active Brains, AB), supported by Fitbit for older adults with chronic pain (CP) and early cognitive decline (ECD). Guided by the principles of the NIH stage model we 1) explore signals of improvement in AB outcomes and hypothesized mechanisms of action and 2) explore relationships between changes in outcomes with changes in mechanisms. METHODS: Participants were N = 15 older adults (age ≥ 60) with CP-ECD from two NIH stage 1 pilot studies of AB. We conducted paired t-tests to explore pre-post improvements, and correlations to investigate associations between changes in outcomes and mechanisms. RESULTS: We observed small to large improvements across co-primary and secondary outcomes (d = 0.24-1.09). We observed small to medium improvements in 4 out of 5 hypothesized mechanisms (d = 0.23-0.47). Overall, improvements in outcomes had moderate to large associations with improvements in hypothesized mechanisms. CONCLUSION: AB was associated with improvements across several co-primary and secondary outcomes, and hypothesized mechanisms. Pain-specific coping and general coping skills are promising treatment targets to address the CP-ECD comorbidity among older adults.