Musculoskeletal Pain in Long-term Dizziness

Not Applicable

Completed

• Conditions: Vestibular Disease; Musculoskeletal Pain; Rehabilitation
• Interventions: Behavioral: Exergaming; Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapy

• Registration Number: NCT04241822
• Lead Sponsor: Western Norway University of Applied Sciences

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2020-08-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exergaming	Exergaming	The intervention is individual and consist of non-immersive virtual reality exercises to improve balance
Vestibular exercises combined with cognitive therapy	Vestibular exercises combined with body awareness exercises and 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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway