RESUMEN
INTRODUCTION: Chronic musculoskeletal pain causes a significant burden on health and quality of life and may result from inadequate treatment of acute musculoskeletal pain. The emergency department (ED) represents a novel setting in which to test non-pharmacological interventions early in the pain trajectory to prevent the transition from acute to chronic pain. Acupuncture is increasingly recognised as a safe, affordable and effective treatment for pain and anxiety in the clinic setting, but it has yet to be established as a primary treatment option in the ED. METHODS AND ANALYSIS: This pragmatic clinical trial uses a two-stage adaptive randomised design to determine the feasibility, acceptability and effectiveness of acupuncture initiated in the ED and continued in outpatient clinic for treating acute musculoskeletal pain. The objective of the first (treatment selection) stage is to determine the more effective style of ED-based acupuncture, auricular acupuncture or peripheral acupuncture, as compared with no acupuncture. All arms will receive usual care at the discretion of the ED provider blinded to treatment arm. The objective of the second (effectiveness confirmation) stage is to confirm the impact of the selected acupuncture arm on pain reduction. An interim analysis is planned at the end of stage 1 based on probability of being the best treatment, after which adaptations will be considered including dropping the less effective arm, sample size re-estimation and unequal treatment allocation ratio (eg, 1:2) for stage 2. Acupuncture treatments will be delivered by licensed acupuncturists in the ED and twice weekly for 1 month afterward in an outpatient clinic. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Duke University Health System Institutional Review Board. Informed consent will be obtained from all participants. Results will be disseminated through peer-review publications and public and conference presentations. TRIAL REGISTRATION NUMBER: NCT04290741.
Asunto(s)
Terapia por Acupuntura , Dolor Agudo , Dolor Crónico , Dolor Musculoesquelético , Dolor Agudo/terapia , Instituciones de Atención Ambulatoria , Servicio de Urgencia en Hospital , Humanos , Dolor Musculoesquelético/terapia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
BACKGROUND: Complementary integrative health therapies have a perioperative role in the reduction of pain, analgesic use, and anxiety, and increasing patient satisfaction. However, long implementation lags have been quantified. The Consolidated Framework for Implementation Research (CFIR) can help mitigate this translational problem. METHODS: We reviewed evidence for several nonpharmacological treatments (CFIR domain: characteristics of interventions) and studied external context and organizational readiness for change by surveying providers at 11 Veterans Affairs (VA) hospitals (domains: outer and inner settings). We asked patients about their willingness to receive music and studied the association between this and known risk factors for opioid use (domain: characteristics of individuals). We implemented a protocol for the perioperative use of digital music players loaded with veteran-preferred playlists and evaluated its penetration in a subgroup of patients undergoing joint replacements over a 6-month period (domain: process of implementation). We then extracted data on postoperative recovery time and other outcomes, comparing them with historic and contemporary cohorts. RESULTS: Evidence varied from strong and direct for perioperative music and acupuncture, to modest or weak and indirect for mindfulness, yoga, and tai chi, respectively. Readiness for change surveys completed by 97 perioperative providers showed overall positive scores (mean >0 on a scale from -2 to +2, equivalent to >2.5 on the 5-point Likert scale). Readiness was higher at Durham (+0.47) versus most other VA hospitals (range +0.05 to +0.63). Of 3307 veterans asked about willingness to receive music, approximately 68% (n = 2252) answered "yes." In multivariable analyses, a positive response (acceptability) was independently predicted by younger age and higher mean preoperative pain scores (>4 out of 10 over 90 days before admission), factors associated with opioid overuse. Penetration was modest in the targeted subset (39 received music out of a possible 81 recipients), potentially reduced by device nonavailability due to diffusion into nontargeted populations. Postoperative recovery time was not changed, suggesting smooth integration into workflow. CONCLUSIONS: CFIR-guided implementation of perioperative music was feasible at a tertiary VA hospital, with moderate penetration in a high-risk subset of patients. Use of digital music players with preferred playlists was supported by strong evidence, tension for change, modest readiness among providers, good acceptability among patients (especially those at risk for opioid overuse), and a protocolized approach. Further study is needed to identify similar frameworks for effective knowledge-translation activities.