Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Anne Welling
ORCID ID
Contact details
Emergency Department
Queen Alexandra Hospital
Cosham
Portsmouth
PO3 6LY
United Kingdom
-
anne.welling@ntlworld.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7442
Study information
Scientific title
The tuning fork test: an accurate and efficient method of improving the diagnostic accuracy of the Ottawa ankle rules
Acronym
Study hypothesis
A mixed method multicentre research study is used to establish the main aim of the study, which is to assess whether the specificity and therefore the diagnostic accuracy of the Ottawa Ankle Rules (OARs) can be improved by using them in conjunction with the Tuning Fork Test (TFT) on patients with twisting ankle injuries.
The study also aims to explore whether the use of the Tuning fork Test is acceptable to patients and staff, and if the results are favourable to compare the actual time spent in the Emergency care setting waiting for x-ray with time a patient could have been discharged if the tuning fork test is negative.
Ethics approval
Southampton and SW Hampshire REC (A) approved on the 12th May 2009 (ref: 09/H0502/57)
Study design
Multicentre randomised interventional diagnosis trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
The tuning fork test consists of activating a 128Hz Gardner Brown tuning fork by holding the tuning fork by the stem and tapping the weighted tines on the fleshy side of the palm. The vibrating tuning fork is then placed at right angles to the body on both ankles. On the injured ankle this will be at the site of maximum tenderness and then 6 cm proximal (above). On the uninjured ankle the tuning fork will be placed at the corresponding sites on the injured ankle.
The study is a mixed methods study incorporating a quantitative diagnostic test study (the tuning fork test) with qualitative focus groups. The diagnostic test study is carried out once participants have been identifed as having bony tenderness to either malleoli of their ankle or the distal fibula shaft. Once consent has been obtained the tuning fork test is carried out, randomised as to which ankle is tested first. In this study the un-injured ankle is used as a control group. the tuning fork test takes approximately 2 - 3 minutes maximum to complete. The participants then receive the standard ankle x-rays as per current practice. At this visit the participants are asked if the study team can contact them to take part in a focus group within 3 months of their visit. Participants are then contacted by letter and offered a choice of attending a focus group, withdrawing their consent to being contacted or giving permission to be contacted after the three month deadline regarding future focus groups. The focus groups last approximately one hour.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The diagnostic accuracy of the Ottawa ankle rules is increased when used in conjunction with the tuning fork test. The tuning fork test and ankle x-rays are interpreted blind and then compared. The number of true and false negatives and positives is compared and will be displayed and analysed in a 2 x 2 table. When collecting the data the research nurse is a ware of the results of both tests but the results will not be analysed until the sample size is met (n = 1300).
Secondary outcome measures
1. Demographics of the patient (i.e., gender, age, ethnicity)
2. Operator experience
Overall trial start date
01/06/2009
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Ability to walk before the injury
2. Minimum age 12 years - no upper age limit, either sex
3. Injury to ankle by simple twisting mechanism - inversion/eversion
4. Identified as Ottawa positive - that is bony tenderness to lateral and/or medial malleolus
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned sample size: 1300
Participant exclusion criteria
1. Inability to give own informed consent
2. Patients who have a history of peripheral neuropathy from any cause
3. Patients who are pregnant will only be included if the risk of x-ray is considered to be less than the risk to the foetus from exposure to x-ray
4. Patients who are unable to walk prior to the incident will not be included as the OARs are designed to be used in patients who can walk before the incident
Recruitment start date
01/06/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Emergency Department
Portsmouth
PO3 6LY
United Kingdom
Sponsor information
Organisation
Portsmouth Hospitals NHS Trust (UK)
Sponsor details
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Insititute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
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