Musculoskeletal Pain in Long-term Dizziness (MUPID)

April 24, 2023 updated by: Liv Heide Magnussen, Western Norway University of Applied Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Unni Moen, Ph.d.student
  • Phone Number: + 4792684699
  • Email: unni.moen@hvl.no

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Experimental: Exergaming
The intervention is individual and consist of non-immersive virtual reality exercises to improve balance
Behavioral: Exergaming
The intervention consists of different balance exercises using non-immersive virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory. 0-100 (high score worst)
Time Frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
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)
Time Frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
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)
Time Frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
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)
Time Frame: Baseline, 26 weeks, 1 year
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)
Time Frame: Baseline, 26 weeks, 1 year
Baseline status and change in anxiety and depression symptoms
Baseline, 26 weeks, 1 year
Dizziness Catastrophising Scale. 0-52 (high score worst)
Time Frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
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.
Time Frame: Baseline,1 year, through study completion, an average 18 months
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
Time Frame: Baseline,1 year, through study completion, an average 18 months
Baseline status and change after intervention
Baseline,1 year, through study completion, an average 18 months
Walking test preferred speed, 6 m (m/s)
Time Frame: Baseline,1 year, through study completion, an average 18 months
Baseline status and change after intervention
Baseline,1 year, through study completion, an average 18 months
Walking test fast speed, 6 m (m/s)
Time Frame: Baseline,1 year, through study completion, an average 18 months
Baseline status and change after intervention
Baseline,1 year, through study completion, an average 18 months
Grip Strength
Time Frame: Baseline
Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Norway University of Applied Sciences

Collaborators

Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

March 31, 2028

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6849

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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