Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucy Yardley

ORCID ID

Contact details

Department of Psychology
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 023 80 594 581
L.Yardley@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SEO083

Study information

Scientific title

Acronym

Study hypothesis

To compare the outcome of nurse-delivered vestibular rehabilitation for dizzy patients in primary care with standard medical care.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Ear, nose and throat diseases

Intervention

Vestibular rehabilitation programme of daily eye, head and body exercises, education about causes and management of symptoms delivered by nurse therapist versus routine medical care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Computerised measurement of postural sway; validated self-report measures of symptoms and quality of life.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2000

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients with current dizziness or vertigo of at least 2 months' duration. Current complaint of dizziness or vertigo for which a vestibular cause is a definite or possible diagnosis; telephone ownership.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Age <18 yrs, disorders contraindicating performance of vigorous head/body exercises (vertebrob asilar ischaemia, severe cervical disorder), diagnosed non-vestibular cause of dizziness, life-threatening or progressive central disorder

Recruitment start date

01/10/2000

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15492339

Publication citations

  1. Results

    Yardley L, Donovan-Hall M, Smith HE, Walsh BM, Mullee M, Bronstein AM, Effectiveness of primary care-based vestibular rehabilitation for chronic dizziness., Ann. Intern. Med., 2004, 141, 8, 598-605.

Additional files

Editorial Notes