Musculoskeletal Pain in Long-term Dizziness

NCT04241822 | Completed

• 1 other identifier: 6849
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disease; Musculoskeletal Pain; Rehabilitation

Keywords

vestibular disease; musculoskeletal pain; prognosis; vestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Nordic Pain Questionnaire. 0-10 (high score worst)

  Baseline, 26 weeks, 1 year, through study completion, an average 18 months

• Vertigo Symptom Scale. 0-60 (high score worst)

  Baseline, 26 weeks, 1 year, through study completion, an average 18 months

• RAND-12 health related quality of life. 0-60 (high score better)

  Baseline, 26 weeks, 1 year

• Hospital Anxiety and Depression Scale. 0-42 (high score worst)

  Baseline, 26 weeks, 1 year

• Dizziness Catastrophising Scale. 0-52 (high score worst)

  Baseline, 26 weeks, 1 year, through study completion, an average 18 months

Study Arms (2)

Vestibular exercises combined with cognitive therapy

EXPERIMENTAL

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

Exergaming

EXPERIMENTAL

The intervention is individual and consist of non-immersive virtual reality exercises to improve balance

Behavioral: Exergaming

Interventions

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

Vestibular exercises combined with cognitive therapy

Exergaming BEHAVIORAL

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

Exergaming

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
• Patients must be bothered with dizziness at the time of consultation

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Norway University of Applied Sciences: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5020, Norway

Location

MeSH Terms

Conditions

Vestibular Diseases; Musculoskeletal Pain

Interventions

Cognitive Behavioral Therapy; Exergaming

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gro Anita F Flaten, ph.d.

  Western Norway University of Applied Sciences

  STUDY DIRECTOR

• Evelyn Neppelberg, ph.d.

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 27, 2020
• Study Start: August 15, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

NO (1)