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

Not Applicable
Completed
Conditions
Vertigo
Dizziness
Vestibular Neuritis
Interventions
Behavioral: BI + VR + CBT
Behavioral: BI + phone calls
Registration Number
NCT02655575
Lead Sponsor
Bergen University College
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
107
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BI + VR + CBTBI + phone callsBrief Intervention (BI) consists of an individual clinical examination, education/information and advice about being active Vestibular Rehabilitation (VR) includes active exercises that provokes dizziness, Balance exercises and body awareness exercises in a group format. Cognitive Behavioral Therapy (CBT) includes conversation and reflection about factors that may be a barrier to Activity and participation
BI + phone callsBI + VR + CBTBrief Intervention (BI) consists of an individual clinical examination, education/information and advice about being active Phone Calls as follow-up at week 2 and 6 to reassure
BI + phone callsBI + phone callsBrief Intervention (BI) consists of an individual clinical examination, education/information and advice about being active Phone Calls as follow-up at week 2 and 6 to reassure
BI + VR + CBTBI + VR + CBTBrief Intervention (BI) consists of an individual clinical examination, education/information and advice about being active Vestibular Rehabilitation (VR) includes active exercises that provokes dizziness, Balance exercises and body awareness exercises in a group format. Cognitive Behavioral Therapy (CBT) includes conversation and reflection about factors that may be a barrier to Activity and participation
Primary Outcome Measures
NameTimeMethod
Dizziness Handicap Inventory (DHI)3 min
6 m walking test preferred velocity5 min

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

Secondary Outcome Measures
NameTimeMethod
Panic Attack Scale (PAS)3 min
Vertigo symptom scale (VSS-SF)3 min
Patient Specific Functional Scale (PSFS)3 min
Subjective Health Complaints (SHC)3 min
Body Sensation Questionnaire (BSQ)3 min
Mobility Index (MI-A)3 min
EQ-5D-5L2 min
Hospital Anxiety and Depression Scale (HADS)3 min
Global Muscle Examination (GME) - flexibility6 min
Hand Grip test2 min
6 m walking test (as fast as possible), mean of two test trials3 min

walk 6 meter as fast as possible

Perceived dizziness before and after 1 min head movements2 min
Patient Global Impression of Change1 min
Dynamic Visual Aquity Test (DVA)2 min
Dual task waling test, 6 m3 min

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

Chalder Fatigue Scale (CFS)1 min
Limits of stability (LOS)2
The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test4 min

Trial Locations

Locations (1)

Bergen University College

🇳🇴

Bergen, Norway

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