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临床试验/NCT02655575
NCT02655575已完成不适用

Assessment and Treatment of Patients With Long-term Dizziness in Primary Care

Bergen University College2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
2
主要终点
Dizziness Handicap Inventory (DHI)

研究概览

简要总结

Brief Summary:

The purpose of the present study is to examine the effects of a Group based intervention consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy (CBT) in patients with long--lasting vestibular dizziness. The study also aims to describe sociodemographic, physical and psychological characteristics in the patients, and to examine prognostic factors related to functional status and disability following participation in the intervention.

Prior to the RCT, a feasibility study will be conducted to examine the feasibility of the study protocol.

详细描述

Dizziness is a common complaint. International studies show a prevalence of balance/dizziness problems in 10-30% in the population, and in Norway it is reported that 11 % of the population have symptoms of dizziness and/or imbalance during the last three months. Peripheral vestibular disorders are the most common cause of dizziness presenting in primary care. Most people recover within a few weeks , but it is assumed that about 30% of the patients do not recover fully from an acute peripheral vestibular disorder and develop long-lasting dizziness, often with secondary musculoskeletal pain and anxiety, making it a multifactorial syndrome. It is unknown if these secondary complaints are issues that maintain or exacerbates the dizziness, or if a high level of musculoskeletal and psychological problems may predict future disability.There is a general consensus that exercises labeled as Vestibular Rehabilitation (VR) is the most effective treatment for vestibular dysfunction. VR exercises involve eye, head and body movements aiming to provoke dizziness, which is a prerequisite for adaptation and recovery. However, not all patients will recover from VR, and therefore increased attention toward the psychological aspects, targeting how patients think about the dizziness has been addressed. Cognitive behavioral therapy (CBT) alone or in addition to VR seems to have limited effect. This present study aims to combine an existing group treatment targeting body awareness and VR with CBT in order to address both the movement provoked dizziness and secondary complaints that patients with long-term dizziness often present with.

Prior to conducting the RCT the feasibility of recruitment procedures, test procedures and the interventions (CBT-VR and BI) will be examined in a feasibility study. The study is judged as feasible if the participants could complete the testing and adhere to the treatment protocols, of they found the intervention appropriate for their complaints, and if the primary outcomes improved following the intervention. Eight participants were planned for the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The dizziness is provoked or aggravated by head movements, more than 3 months duration og symptoms, the dizziness started acute, understand Norwegian

排除标准

  • Dizziness no longer a problem, other known reasons, than vestibular, for the dizziness (neurological, psychological, or cancer), fluctuating vestibular disease (e.g, ménières disease), scheduled for treatment of/ have had treatment for benign paroxysmal positional vertigo within one month,conditions where fast head movements are contraindicated (e.g. osteoporosis of the neck, whiplash associated injuries), participated in group therapy for dizziness within the past year, unable to attend test and treatment locations

结局指标

主要结局

Dizziness Handicap Inventory (DHI)

时间窗: 3 min

6 m walking test preferred velocity

时间窗: 5 min

6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials

次要结局

  • Panic Attack Scale (PAS)(3 min)
  • Vertigo symptom scale (VSS-SF)(3 min)
  • Patient Specific Functional Scale (PSFS)(3 min)
  • Subjective Health Complaints (SHC)(3 min)
  • Body Sensation Questionnaire (BSQ)(3 min)
  • Mobility Index (MI-A)(3 min)
  • EQ-5D-5L(2 min)
  • Hospital Anxiety and Depression Scale (HADS)(3 min)
  • Global Muscle Examination (GME) - flexibility(6 min)
  • Hand Grip test(2 min)
  • 6 m walking test (as fast as possible), mean of two test trials(3 min)
  • Perceived dizziness before and after 1 min head movements(2 min)
  • Patient Global Impression of Change(1 min)
  • Dynamic Visual Aquity Test (DVA)(2 min)
  • Dual task waling test, 6 m(3 min)
  • Chalder Fatigue Scale (CFS)(1 min)
  • Limits of stability (LOS)(2)
  • The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test(4 min)

研究者

发起方
Bergen University College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liv Heide Magnussen

Associated Professor, ph.d.

Bergen University College

研究点 (2)

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