Musculoskeletal Pain in Long-term Dizziness

Rehabilitation Clinical Trial

— MUPID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04241822
• Other study ID #: 6849
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2023
• Source: Western Norway University of Applied Sciences
• Contact: Liv H Magnussen, Professor
• Phone: +4755585631
• Email: liv.magnussen[@]hvl.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2028
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Musculoskeletal Pain
• Rehabilitation
• Vestibular Disease
• Vestibular Diseases

Intervention

Behavioral:
• 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
• Exergaming
The intervention consists of different balance exercises using non-immersive virtual reality

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Western Norway University of Applied Sciences	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Hospital Anxiety and Depression Scale. 0-42 (high score worst)	Baseline status and change in anxiety and depression symptoms	Baseline, 26 weeks, 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Walking test preferred speed, 6 m (m/s)	Baseline status and change after intervention	Baseline,1 year, through study completion, an average 18 months
Secondary	Walking test fast speed, 6 m (m/s)	Baseline status and change after intervention	Baseline,1 year, through study completion, an average 18 months
Secondary	Grip Strength	Baseline	Baseline