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Completed

NCT Number: NCT02655575

Assessment and Treatment of Patients With Long-term Dizziness in Primary Care

Brief Summary:

The purpose of the present study is to examine the effects of a Group based intervention consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy (CBT) in patients with long--lasting vestibular dizziness. The study also aims to describe sociodemographic, physical and psychological characteristics in the patients, and to examine prognostic factors related to functional status and disability following participation in the intervention.

Prior to the RCT, a feasibility study will be conducted to examine the feasibility of the study protocol.

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Key information

About this study

Dizziness is a common complaint. International studies show a prevalence of balance/dizziness problems in 10-30% in the population, and in Norway it is reported that 11 % of the population have symptoms of dizziness and/or imbalance during the last three months. Peripheral vestibular disorders are the most common cause of dizziness presenting in primary care. Most people recover within a few weeks , but it is assumed that about 30% of the patients do not recover fully from an acute peripheral vestibular disorder and develop long-lasting dizziness, often with secondary musculoskeletal pain and anxiety, making it a multifactorial syndrome. It is unknown if these secondary complaints are issues that maintain or exacerbates the dizziness, or if a high level of musculoskeletal and psychological problems may predict future disability.There is a general consensus that exercises labeled as Vestibular Rehabilitation (VR) is the most effective treatment for vestibular dysfunction. VR exercises involve eye, head and body movements aiming to provoke dizziness, which is a prerequisite for adaptation and recovery. However, not all patients will recover from VR, and therefore increased attention toward the psychological aspects, targeting how patients think about the dizziness has been addressed. Cognitive behavioral therapy (CBT) alone or in addition to VR seems to have limited effect. This present study aims to combine an existing group treatment targeting body awareness and VR with CBT in order to address both the movement provoked dizziness and secondary complaints that patients with long-term dizziness often present with.

Prior to conducting the RCT the feasibility of recruitment procedures, test procedures and the interventions (CBT-VR and BI) will be examined in a feasibility study. The study is judged as feasible if the participants could complete the testing and adhere to the treatment protocols, of they found the intervention appropriate for their complaints, and if the primary outcomes improved following the intervention. Eight participants were planned for the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The dizziness is provoked or aggravated by head movements, more than 3 months duration og symptoms, the dizziness started acute, understand Norwegian

Exclusion criteria

  • Dizziness no longer a problem, other known reasons, than vestibular, for the dizziness (neurological, psychological, or cancer), fluctuating vestibular disease (e.g, ménières disease), scheduled for treatment of/ have had treatment for benign paroxysmal positional vertigo within one month,conditions where fast head movements are contraindicated (e.g. osteoporosis of the neck, whiplash associated injuries), participated in group therapy for dizziness within the past year, unable to attend test and treatment locations

Treatment and study plan

BI + VR + CBT

Behavioral

Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy

Other names: Brief intervention (BI), Vestibular rehabilitation (VR), Cognitive behavioral therapy (CBT)

BI + phone calls

Behavioral

Brief intervention (information and advice). Patients are followed-up by phone calls

Other names: Brief intervention (BI)

Primary outcomes

  1. Dizziness Handicap Inventory (DHI)

    Time frame: 3 min

  2. 6 m walking test preferred velocity

    Time frame: 5 min

    6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials

Secondary outcomes

  1. Vertigo symptom scale (VSS-SF)

    Time frame: 3 min

  2. Patient Specific Functional Scale (PSFS)

    Time frame: 3 min

  3. Subjective Health Complaints (SHC)

    Time frame: 3 min

  4. Body Sensation Questionnaire (BSQ)

    Time frame: 3 min

  5. Mobility Index (MI-A)

    Time frame: 3 min

  6. Panic Attack Scale (PAS)

    Time frame: 3 min

  7. EQ-5D-5L

    Time frame: 2 min

  8. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 min

  9. Global Muscle Examination (GME) - flexibility

    Time frame: 6 min

  10. Patient Global Impression of Change

    Time frame: 1 min

  11. Dynamic Visual Aquity Test (DVA)

    Time frame: 2 min

  12. Hand Grip test

    Time frame: 2 min

  13. 6 m walking test (as fast as possible), mean of two test trials

    Time frame: 3 min

    walk 6 meter as fast as possible

  14. Dual task waling test, 6 m

    Time frame: 3 min

    6 meter walking test, optional speed, while doing a cognitive task

  15. Perceived dizziness before and after 1 min head movements

    Time frame: 2 min

  16. The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test

    Time frame: 4 min

  17. Chalder Fatigue Scale (CFS)

    Time frame: 1 min

  18. Limits of stability (LOS)

    Time frame: 2

Sponsors and collaborators

Lead sponsor

Bergen University College

Other

Collaborators

  • Duke University
  • Haukeland University Hospital
  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • University of Bergen
  • University of Southern Denmark

Registry information

Acronym: LODIP

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2016
Registry last updated
Feb 5, 2025

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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