Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial.

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.

Response to Powell et al., "Do Hearing Aids Prevent Falls? Commentary on Study From the National Health and Nutrition Examination Survey".

PURPOSE: This letter serves to respond to Powell et al.'s (2021) letter to the editor regarding our recent publication, "Preliminary Evidence on the Impact of Hearing Aid Use on Falls Risk in Individuals With Self-Reported Hearing Loss." In our letter, we respond to key concerns and commentary raised by the authors.

Preliminary Evidence on the Impact of Hearing Aid Use on Falls Risk in Individuals With Self-Reported Hearing Loss.

Purpose Falls are considered a significant public health issue, and hearing loss has been shown to be an independent risk factor for falls. The primary objective of this study was to determine if hearing aid use modified (reduced) the association. We hypothesized that routine hearing aid use would reduce the impact of hearing loss on the odds of falling. If hearing aid users have reduced odds of falling, then that would have an important impact on falls prevention health care. Method Data from 8,091 individuals 40 years of age and older who completed National Health and Nutrition Examination Survey (NHANES) cycles 1999-2004 were used. NHANES comprises a series of cross-sectional studies, each of which is representative of the total civilian noninstitutionalized population of children and adults in the United States, enabling unbiased national estimates of health that can be independently reproduced. Self-reported hearing, hearing aid status, falls history, and comorbidities were extracted and analyzed using regression modeling. Results The 8,091 individuals were grouped based on a self-reported history of falls in the last year. Self-reported hearing loss was significantly associated with odds of falling. Categorizing individuals based on routine hearing aid use was included as an interaction term in the fully adjusted models and was not significant, suggesting no difference in falls based on hearing aid status. Conclusions The unique results of the current study show that when examining self-reported hearing in a nationally representative sample, hearing aid use does not appear to mitigate or modify the association between self-reported hearing and falls. Future research designs are highlighted to address limitations identified using NHANES data for this research and focus on the use of experimental designs to further understand the association between hearing loss and falls, including whether hearing loss may be a modifiable risk factor for falls. Supplemental Material https://doi.org/10.23641/asha.14642784.