Clinical trial NCT04241822: Musculoskeletal Pain in Long-term Dizziness
Official title: Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disease
Musculoskeletal Pain
Rehabilitation
Keywords: vestibular disease
musculoskeletal pain
prognosis
vestibular rehabilitation
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2020-01-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dizziness Handicap Inventory. 0-100 (high score worst)
timeFrame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Secondary outcomes:
measure: Nordic Pain Questionnaire. 0-10 (high score worst)
timeFrame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
measure: Vertigo Symptom Scale. 0-60 (high score worst)
timeFrame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
measure: RAND-12 health related quality of life. 0-60 (high score better)
timeFrame: Baseline, 26 weeks, 1 year
measure: Hospital Anxiety and Depression Scale. 0-42 (high score worst)
timeFrame: Baseline, 26 weeks, 1 year
measure: Dizziness Catastrophising Scale. 0-52 (high score worst)
timeFrame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
measure: Posturography. Body sway while standing on a force platform.
timeFrame: Baseline,1 year, through study completion, an average 18 months
measure: Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52
timeFrame: Baseline,1 year, through study completion, an average 18 months
measure: Walking test preferred speed, 6 m (m/s)
timeFrame: Baseline,1 year, through study completion, an average 18 months
measure: Walking test fast speed, 6 m (m/s)
timeFrame: Baseline,1 year, through study completion, an average 18 months
measure: Grip Strength
timeFrame: Baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Western Norway University of Applied Sciences
name: Gro Anita F Flaten, ph.d.
role: STUDY_DIRECTOR
affiliation: Haukeland University Hospital
name: Evelyn Neppelberg, ph.d.
role: STUDY_DIRECTOR
References: