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NCT Number: NCT04241822

Musculoskeletal Pain in Long-term Dizziness

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.

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Key information

Conditions

Vestibular Disease Ear Diseases Labyrinth Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Rehabilitation Signs and Symptoms Vestibular Diseases

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5020, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular exercises combined with body awareness exercises and cognitive therapy

Behavioral

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

Behavioral

The intervention consists of different balance exercises using non-immersive virtual reality

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Western Norway University of Applied Sciences

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

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

Acronym: MUPID

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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