Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Anne Welling


Contact details

Emergency Department
Queen Alexandra Hospital
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The tuning fork test: an accurate and efficient method of improving the diagnostic accuracy of the Ottawa ankle rules


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


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Emergency Department
United Kingdom

Sponsor information


Portsmouth Hospitals NHS Trust (UK)

Sponsor details

Southwick Hill Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Insititute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator”