Musculoskeletal Pain in Long-term Dizziness

Study 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.

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

Conditions
-----------------
Vestibular Disease, Musculoskeletal Pain, Rehabilitation

Intervention / Treatment
-----------------
* Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapy
* Behavioral: Exergaming


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After 1 year participants who still have dizziness complaints will be offered one of two interventions: Group-based vestibular rehabilitation combining cognitive intervention, vestiular exercises and body awareness therapy Exergaming intervention with virtual reality exercises using data games and videos, and other balance exercises.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular exercises combined with cognitive therapy<br>The intervention is in groups of 8-10 patients. The interventions consists of cognitive therapy, vestibular exercises and body awareness therapy, 8 group sessions | Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapy<br>* 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<br>|
| Experimental: Exergaming<br>The intervention is individual and consist of non-immersive virtual reality exercises to improve balance | Behavioral: Exergaming<br>* The intervention consists of different balance exercises using non-immersive virtual reality<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory. 0-100 (high score worst) | Baseline status and change in dizziness handicap | Baseline, 26 weeks, 1 year, through study completion, an average 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nordic Pain Questionnaire. 0-10 (high score worst) | Baseline status and change in musculoskeletal pain | Baseline, 26 weeks, 1 year, through study completion, an average 18 months | 
| Vertigo Symptom Scale. 0-60 (high score worst) | Baseline status and change in vertigo symptoms | Baseline, 26 weeks, 1 year, through study completion, an average 18 months | 
| RAND-12 health related quality of life. 0-60 (high score better) | Baseline status and change in health related quality of life | Baseline, 26 weeks, 1 year | 
| Hospital Anxiety and Depression Scale. 0-42 (high score worst) | Baseline status and change in anxiety and depression symptoms | Baseline, 26 weeks, 1 year | 
| Dizziness Catastrophising Scale. 0-52 (high score worst) | Baseline status and change in catastrophising thoughts about the dizziness | Baseline, 26 weeks, 1 year, through study completion, an average 18 months | 
| Posturography. Body sway while standing on a force platform. | Baseline status and change after intervention | Baseline,1 year, through study completion, an average 18 months | 
| Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52 | Baseline status and change after intervention | Baseline,1 year, through study completion, an average 18 months | 
| Walking test preferred speed, 6 m (m/s) | Baseline status and change after intervention | Baseline,1 year, through study completion, an average 18 months | 
| Walking test fast speed, 6 m (m/s) | Baseline status and change after intervention | Baseline,1 year, through study completion, an average 18 months | 
| Grip Strength | Baseline | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prognosis, vestibular disease, musculoskeletal pain, vestibular rehabilitation