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临床试验/NCT04241822
NCT04241822已完成不适用

Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures

Western Norway University of Applied Sciences2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年8月15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
150
试验地点
2
主要终点
Dizziness Handicap Inventory. 0-100 (high score worst)

研究概览

简要总结

This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. The purpose of the project is to strengthen the knowledge base regarding symptom burden, prognosis and treatment of prolonged dizziness. The hypothesis is that musculoskeletal pain at baseline is a prognostic factor for prolonged dizziness.

详细描述

Patients referred to an tertiary otorhinolarynglogical clinic due to dizziness will be invited to participate in the study. The aims are to examine the prevalence, extent and distribution of musculoskeletal pain in patients with prolonged dizziness, and to investigate the associations between musculoskeletal pain, dizziness symptoms, psychological and physical function and health-related quality of life.

Furthermore, the aim is to monitor the natural course of the dizziness symptoms and functional status in these patients, and examine risk factors for prolonged disability after 6 and 12 months. The hypothesis is that muscle pain and distress at baseline may be independently associated with prolonged complaints at follow-up.

Finally, patients who still are dizzy and have pain after 12 months will be invited to participate in one of two group interventions a) modified vestibular rehabilitation and b) virtual reality / exergaming. The interventions will be feasibility studies with a pre-post design.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
  • Patients must be bothered with dizziness at the time of consultation

排除标准

  • Patients uable to fill in questionnaires due language barriers
  • Patients not able to undergo diagnostic and testing procedures
  • Patients with vestibular Schwannoma
  • Patients with diving-related inner ear injuries

结局指标

主要结局

Dizziness Handicap Inventory. 0-100 (high score worst)

时间窗: Baseline, 26 weeks, 1 year, through study completion, an average 18 months

Baseline status and change in dizziness handicap

次要结局

  • Walking test fast speed, 6 m (m/s)(Baseline,1 year, through study completion, an average 18 months)
  • Posturography. Body sway while standing on a force platform.(Baseline,1 year, through study completion, an average 18 months)
  • Grip Strength(Baseline)
  • RAND-12 health related quality of life. 0-60 (high score better)(Baseline, 26 weeks, 1 year)
  • Hospital Anxiety and Depression Scale. 0-42 (high score worst)(Baseline, 26 weeks, 1 year)
  • Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52(Baseline,1 year, through study completion, an average 18 months)
  • Vertigo Symptom Scale. 0-60 (high score worst)(Baseline, 26 weeks, 1 year, through study completion, an average 18 months)
  • Dizziness Catastrophising Scale. 0-52 (high score worst)(Baseline, 26 weeks, 1 year, through study completion, an average 18 months)
  • Nordic Pain Questionnaire. 0-10 (high score worst)(Baseline, 26 weeks, 1 year, through study completion, an average 18 months)
  • Walking test preferred speed, 6 m (m/s)(Baseline,1 year, through study completion, an average 18 months)

研究者

发起方
Western Norway University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liv Heide Magnussen

Professor

Western Norway University of Applied Sciences

研究点 (2)

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