Musculoskeletal Pain in Long-term Dizziness

NCT ID: NCT04241822

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Vestibular Disease Musculoskeletal Pain Rehabilitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

After 1 year participants who still have dizziness complaints will be offered one of two interventions:

1. Group-based vestibular rehabilitation combining cognitive intervention, vestiular exercises and body awareness therapy
2. Exergaming intervention with virtual reality exercises using data games and videos, and other balance exercises.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vestibular exercises combined with cognitive therapy

The intervention is in groups of 8-10 patients. The interventions consists of cognitive therapy, vestibular exercises and body awareness therapy, 8 group sessions

Group Type EXPERIMENTAL

Vestibular exercises combined with body awareness exercises and cognitive therapy

Intervention Type BEHAVIORAL

The intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy

Exergaming

The intervention is individual and consist of non-immersive virtual reality exercises to improve balance

Group Type EXPERIMENTAL

Exergaming

Intervention Type BEHAVIORAL

The intervention consists of different balance exercises using non-immersive virtual reality

Interventions

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Vestibular exercises combined with body awareness exercises and cognitive therapy

The intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy

Intervention Type BEHAVIORAL

Exergaming

The intervention consists of different balance exercises using non-immersive virtual reality

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Liv Heide Magnussen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gro Anita F Flaten, ph.d.

Role: STUDY_DIRECTOR

Western Norway University of Applied Sciences

Evelyn Neppelberg, ph.d.

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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6849

Identifier Type: -

Identifier Source: org_study_id

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