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Musculoskeletal Pain in Long-term Dizziness (MUPID)

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ClinicalTrials.gov Identifier: NCT04241822
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Liv Heide Magnussen, 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.

Condition or disease Intervention/treatment Phase
Vestibular Disease Musculoskeletal Pain Rehabilitation Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapy Behavioral: Exergaming Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures
Estimated Study Start Date : August 15, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Grip Strength [ Time Frame: Baseline ]
    Baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241822


Contacts
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Contact: Liv H Magnussen, Professor +4755585631 liv.magnussen@hvl.no
Contact: Unni Moen, Ph.d.student + 4792684699 unni.moen@hvl.no

Sponsors and Collaborators
Western Norway University of Applied Sciences
Haukeland University Hospital
Investigators
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Study Director: Gro Anita F Flaten, ph.d. Western Norway University of Applied Sciences
Study Director: Evelyn Neppelberg, ph.d. Haukeland University Hospital
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Responsible Party: Liv Heide Magnussen, Professor, Western Norway University of Applied Sciences
ClinicalTrials.gov Identifier: NCT04241822    
Other Study ID Numbers: 6849
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liv Heide Magnussen, Western Norway University of Applied Sciences:
vestibular disease
musculoskeletal pain
prognosis
vestibular rehabilitation
Additional relevant MeSH terms:
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Musculoskeletal Pain
Vestibular Diseases
Dizziness
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Sensation Disorders
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases