Clinical trial NCT02655575: Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
Official title: Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Vertigo
Vestibular Neuritis
Keywords: dizziness
cognitive therapy
primary care
vestibular rehabilitation
chronic
Lead sponsor: Bergen University College
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: University of Southern Denmark
name: Duke University
name: Haukeland University Hospital
First posted: 2016-01-14
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: 3 min
measure: 6 m walking test preferred velocity
timeFrame: 5 min
Secondary outcomes:
measure: Vertigo symptom scale (VSS-SF)
timeFrame: 3 min
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 3 min
measure: Subjective Health Complaints (SHC)
timeFrame: 3 min
measure: Body Sensation Questionnaire (BSQ)
timeFrame: 3 min
measure: Mobility Index (MI-A)
timeFrame: 3 min
measure: Panic Attack Scale (PAS)
timeFrame: 3 min
measure: EQ-5D-5L
timeFrame: 2 min
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 min
measure: Global Muscle Examination (GME) - flexibility
timeFrame: 6 min
measure: Patient Global Impression of Change
timeFrame: 1 min
measure: Dynamic Visual Aquity Test (DVA)
timeFrame: 2 min
measure: Hand Grip test
timeFrame: 2 min
measure: 6 m walking test (as fast as possible), mean of two test trials
timeFrame: 3 min
measure: Dual task waling test, 6 m
timeFrame: 3 min
measure: Perceived dizziness before and after 1 min head movements
timeFrame: 2 min
measure: The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test
timeFrame: 4 min
measure: Chalder Fatigue Scale (CFS)
timeFrame: 1 min
measure: Limits of stability (LOS)
timeFrame: 2
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen University College
Study officials:
affiliation: Bergen University College
name: Gro AF Flaten, ph.d.
role: STUDY_DIRECTOR
References:
citation: Kristiansen L, Magnussen LH, Wilhelmsen KT, Maeland S, Nordahl SHG, Clendaniel R, Hovland A, Juul-Kristensen B. Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial. Trials. 2019 Oct 7;20(1):575. doi: 10.1186/s13063-019-3660-5.
citation: Kristiansen L, Magnussen LH, Juul-Kristensen B, Maeland S, Nordahl SHG, Hovland A, Sjobo T, Wilhelmsen KT. Feasibility of integrating vestibular rehabilitation and cognitive behaviour therapy for people with persistent dizziness. Pilot Feasibility Stud. 2019 May 20;5:69. doi: 10.1186/s40814-019-0452-3. eCollection 2019.