Non-surgical treatment of benign paroxysmal positional vertigo (BPPV) - a randomised controlled trial of procedures and practices

Author(s):  
R Palaniappan
BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046510
Author(s):  
Cristina García-Muñoz ◽  
María-Dolores Cortés-Vega ◽  
Juan Carlos Hernández-Rodríguez ◽  
Rocio Palomo-Carrión ◽  
Rocío Martín-Valero ◽  
...  

IntroductionVestibular disorders in multiple sclerosis (MS) could have central or peripheral origin. Although the central aetiology is the most expected in MS, peripheral damage is also significant in this disease. The most prevalent effect of vestibular peripheral damage is benign paroxysmal positional vertigo (BPPV). Impairments of the posterior semicircular canals represent 60%–90% of cases of BPPV. The standard gold treatment for this syndrome is the Epley manoeuvre (EM), the effectiveness of which has been poorly studied in patients with MS. Only one retrospective research study and a case study have reported encouraging results for EM with regard to resolution of posterior semicircular canal BPPV. The aim of this future randomised controlled trial (RCT) is to assess the effectiveness of EM for BPPV in participants with MS compared with a sham manoeuvre.Methods and analysisThe current protocol describes an RCT with two-arm, parallel-group design. Randomisation, concealed allocation and double-blinding will be conducted to reduce possible bias. Participants and evaluators will be blinded to group allocation. At least 80 participants who meet all eligibility criteria will be recruited. Participants will have the EM or sham manoeuvre performed within the experimental or control group, respectively. The primary outcome of the study is changes in the Dix Hallpike test. The secondary outcome will be changes in self-perceived scales: Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily Living Scale. The sample will be evaluated at baseline, immediately after the intervention and 48 hours postintervention.Ethics and disseminationThe study was approved by the Andalusian Review Board and Ethics Committee of Virgen Macarena-Virgen del Rocio Hospitals (ID 0107-N-20, 23 July 2020). The results of the research will be disseminated by the investigators to peer-reviewed journals.Trial registration numberNCT04578262.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026711
Author(s):  
Peixia Wu ◽  
Wenzhu Cao ◽  
Yan Hu ◽  
Huawei Li

IntroductionBenign paroxysmal positional vertigo (BPPV) is recognised as the leading cause of peripheral vertigo in adults. The canalith repositioning procedure (CRP) can be used for effective treatment of BPPV. However, some patients experience residual dizziness (RD) even after successful CRP, resulting in a significant negative impact on their daily function and quality of life. Exercise-based vestibular rehabilitation (VR) has been proven as an effective method for managing dizziness and has been applied in patients with various vestibular disorders. However, the efficacy of VR to specifically target RD post-BPPV is unknown. This study aims to investigate the efficacy of VR, compared with betahistine or VR plus betahistine treatment, in the treatment of patients experiencing RD after successful CRP.Methods and analysisA randomised single-blinded controlled trial will be carried out to determine the efficacy of VR compared with betahistine or VR plus betahistine treatment in mitigating RD and improving balance function. Patients with BPPV who experience RD after successful CRP will be recruited. Participants will be randomised into one of three groups to receive VR, betahistine or VR plus betahistine. There will be 61 participants in each group. The primary outcomes will be changes in the patient’s daily function as measured by the Vestibular Activities and Participation questionnaire and balance ability assessed by computerised dynamic posturography. The secondary outcomes will be dizziness-related handicap, otolith function and duration of RD symptoms. Outcome measures will be noted at baseline and at 2, 4 and 8 weeks post-randomisation. This study has the potential to reduce unnecessary anti-vertigo drug prescriptions and may lead to a general consensus regarding the use of VR as a first-line treatment for RD in patients with BPPV.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2017046). The study results will be disseminated via peer-reviewed journals and conferences.Trial registration numberNCT03624283; Pre-results.


BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
J. Marsden ◽  
M. Pavlou ◽  
R. Dennett ◽  
A. Gibbon ◽  
R. Knight-Lozano ◽  
...  

Abstract Background Symptoms arising from vestibular system dysfunction are observed in 49–59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people with MS, vestibular dysfunction can be due to peripheral pathology that may include Benign Paroxysmal Positional Vertigo (BPPV), as well as central or combined pathology. Vestibular symptoms may be treated with vestibular rehabilitation (VR), and with repositioning manoeuvres in the case of BPPV. However, there is a paucity of evidence about the rate and degree of symptom recovery with VR for people with MS and vestibulopathy. In addition, given the multiplicity of symptoms and underpinning vestibular pathologies often seen in people with MS, a customised VR approach may be more clinically appropriate and cost effective than generic booklet-based approaches. Likewise, BPPV should be identified and treated appropriately. Methods/ design People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV. Following consent, people with BPPV will be treated with re-positioning manoeuvres over 1–3 sessions and followed up at 6 and 12 months to assess for any re-occurrence of BPPV. People with central and/or peripheral vestibulopathy will be entered into a randomised controlled trial (RCT). Trial participants will be randomly allocated (1:1) to either a 12-week generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme. Customised or booklet-based interventions will start 2 weeks after randomisation and all trial participants will be followed up 14 and 26 weeks from randomisation. The primary clinical outcome is the Dizziness Handicap Inventory at 26 weeks and the primary economic endpoint is quality-adjusted life-years. A range of secondary outcomes associated with vestibular function will be used. Discussion If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS. Trial registration ISRCTN Number: 27374299 Date of Registration 24/09/2018 Protocol Version 15 25/09/2019


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030578
Author(s):  
Konstantinos Pazarlis ◽  
Anna Punga ◽  
Nikos Schizas ◽  
Bengt Sandén ◽  
Karl Michaëlsson ◽  
...  

IntroductionSymptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis. The study includes a multidimensional follow-up, aiming to study the association between outcome and other studied parameters, mainly electromyography and nerve conduction. Moreover, it may contribute to a better understanding of the pathophysiology of lumbar stenosis and to the development of future pharmacological treatments.Methods and analysisUppSten is a single-centre randomised controlled trial in which 150 patients with symptomatic lumbar spinal stenosis will be randomised into one of two treatment arms. The patients in the surgical arm will undergo laminectomy; the patients in the non-surgical arm will be given a structured physical training programme. The primary outcome of the study will be the Oswestry Disability Index. Secondary outcomes will include motor amplitude and degree of denervation activity obtained by means of nerve conduction studies and electromyography. Patient-reported outcome measures will be also used as secondary outcomes. Blood sample analysis and the investigation of potential inflammation markers are the additional secondary outcome parameters. Laboratory evaluation will include blood sample collection before the treatment initiation and after 6 months. Flavum ligament biopsies will be performed in the surgical group. Finally, tertiary outcomes will include neurophysiological measures, the objective walking ability and radiological evaluation.Ethics and disseminationThe study is approved by the Local Ethics Committee (Dnr 2017–506), the Hospital’s Clinical Trials Committee (2018–0001) and the National Biobank Council and Uppsala Biobank (BbA-827-2018-025). The results will be presented in peer-reviewed journals and at international conferences.Trial registration numberNCT03495661


BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e033150 ◽  
Author(s):  
Flavia K Borges ◽  
P J Devereaux ◽  
Meaghan Cuerden ◽  
Mohit Bhandari ◽  
Ernesto Guerra-Farfán ◽  
...  

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.


BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028537 ◽  
Author(s):  
Flavia K Borges ◽  
Mohit Bhandari ◽  
Ameen Patel ◽  
Victoria Avram ◽  
Ernesto Guerra-Farfán ◽  
...  

IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.


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