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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02655575
Acronym
LODIP
Enrollment
107
Registered
2016-01-14
Start date
2015-10-31
Completion date
2022-05-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dizziness, Vertigo, Vestibular Neuritis

Keywords

dizziness, cognitive therapy, primary care, vestibular rehabilitation, chronic

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALBI + VR + CBT

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

BEHAVIORALBI + phone calls

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

Sponsors

University of Bergen
CollaboratorOTHER
Norwegian Fund for Postgraduate Training in Physiotherapy
CollaboratorOTHER
University of Southern Denmark
CollaboratorOTHER
Duke University
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
Bergen University College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
6 m walking test preferred velocity5 min6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials
Dizziness Handicap Inventory (DHI)3 min

Secondary

MeasureTime frameDescription
Subjective Health Complaints (SHC)3 min
Body Sensation Questionnaire (BSQ)3 min
Mobility Index (MI-A)3 min
Panic Attack Scale (PAS)3 min
EQ-5D-5L2 min
Hospital Anxiety and Depression Scale (HADS)3 min
Global Muscle Examination (GME) - flexibility6 min
Patient Global Impression of Change1 min
Vertigo symptom scale (VSS-SF)3 min
Hand Grip test2 min
6 m walking test (as fast as possible), mean of two test trials3 minwalk 6 meter as fast as possible
Dual task waling test, 6 m3 min6 meter walking test, optional speed, while doing a cognitive task
Perceived dizziness before and after 1 min head movements2 min
The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test4 min
Chalder Fatigue Scale (CFS)1 min
Limits of stability (LOS)2
Dynamic Visual Aquity Test (DVA)2 min
Patient Specific Functional Scale (PSFS)3 min

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026