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Clinical Trials/NCT04241822
NCT04241822
Completed
Not Applicable

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

Western Norway University of Applied Sciences1 site in 1 country150 target enrollmentAugust 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vestibular Disease
Sponsor
Western Norway University of Applied Sciences
Enrollment
150
Locations
1
Primary Endpoint
Dizziness Handicap Inventory. 0-100 (high score worst)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2020
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Western Norway University of Applied Sciences
Responsible Party
Principal Investigator
Principal Investigator

Liv Heide Magnussen

Professor

Western Norway University of Applied Sciences

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months

Baseline status and change in dizziness handicap

Secondary Outcomes

  • 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)

Study Sites (1)

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