RESUMEN
Background: Benign paroxysmal positional vertigo (BPPV) affects approximately half of acute, moderate-severe traumatic brain injury (TBI) patients. To date, there have been no rigorous studies of BPPV assessment or treatment in this cohort. We aimed to determine the safety, practicability, and efficacy of therapist-led BPPV management in acute TBI and the feasibility of a larger effectiveness trial. Methods: This was a multi-centre, three-arm, parallel-groups, randomised, feasibility trial. Recruitment was via convenience sampling. The main inclusion criteria were age over 18 years and a confirmed, non-penetrating, acute TBI. BPPV-positive patients were randomly allocated to one of three interventions (repositioning manoeuvres, Brandt-Daroff exercises or advice) using minimisation criteria. Outcome assessors were blinded to the intervention. Results: Of 2014 patients screened for inclusion, 180 were assessed for BPPV. Of those assessed, 34% (62/180) had BPPV, and 58 patients received an intervention. Therapist-led interventions were delivered safely and accurately according to intervention monitoring criteria. Resolution of BPPV was observed in 35/58 (60%) patients. The resolution rate was highest following repositioning manoeuvres (78%), followed by the advice (53%) and Brandt-Daroff interventions (42%). 10 patients experienced recurrence. This was observed more frequently in those with skull fractures and bilateral or mixed BPPV. Conclusions: Overall, the results provide strong evidence for the feasibility of a future trial. Therapist-led management of BPPV in acute TBI was safe and practicable. Repositioning manoeuvres seemingly yielded a superior treatment effect. However, given the high recurrence rate of post-traumatic BPPV, the optimal time to treat according to patients' specific recurrence risk requires further investigation. Trial registration: ISRCTN91943864, https://doi.org/10.1186/ISRCTN91943864.
RESUMEN
BACKGROUND: Traumatic brain injury (TBI) is the leading cause of long-term disability in working age adults. Recent studies show that most acute TBI patients demonstrate vestibular features of dizziness and imbalance, often from combined peripheral and central vestibular dysfunction. Effective treatment for vestibular impairments post-TBI is important given its significant adverse impact upon quality of life and employment prospects. The most frequent peripheral vestibular disorder in acute TBI is benign paroxysmal positional vertigo (BPPV), affecting approximately half of acute cases. Although there is effective treatment for idiopathic BPPV, there are no high-quality clinical data for post-TBI BPPV regarding its prevalence, natural history, which treatment is most effective and when is the best time to treat. In particular, observational studies suggest post-TBI BPPV may be recurrent, indicating that hyperacute treatment of BPPV may be futile. Given the potential hurdles and the lack of accurate post-TBI BPPV data, the current study was designed to provide information regarding the feasibility and optimal design of future large-scale prospective treatment studies that would compare different interventions and their timing for post-TBI BPPV. METHOD: A multi-centre randomised mixed methods feasibility study design was employed. We aim to recruit approximately 75 acute TBI patients across a range of clinical severities, from three major trauma centres in London. Patients will be randomised to one of three treatment arms: (1) therapist-led manoeuvres, (2) patient-led exercises and (3) advice. Participants will be re-assessed by blinded outcome assessors at 4 and 12 weeks. Acceptability of the intervention will be obtained by patient interviews at the end of their treatment and therapist interviews at the end of the study. Primary outcomes relate to feasibility parameters including recruitment and retention rates, adverse events and intervention fidelity. We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward. DISCUSSION: The multi-centre nature of our feasibility study will inform the design of a future prospective treatment trial of BPPV in acute TBI. Important parameters we will obtain from this study, key for designing a future prospective treatment study, include estimating the prevalence of BPPV in TBI patients admitted to UK major trauma wards, and elucidating both patient and care-provider barriers in delivering BPPV treatment. TRIAL REGISTRATION: ISRCTN, ISRCTN91943864. Registered on 10 February 2020.