Tuning fork testing on ankle injuries

ISRCTN	ISRCTN18630663
DOI	https://doi.org/10.1186/ISRCTN18630663
Secondary identifying numbers	7442

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 21/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mrs Anne Welling
Scientific

Emergency Department
Queen Alexandra Hospital
Cosham
Portsmouth
PO3 6LY
United Kingdom

Email	anne.welling@ntlworld.com

Study information

Study design	Multicentre randomised interventional diagnosis trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The tuning fork test: an accurate and efficient method of improving the diagnostic accuracy of the Ottawa ankle rules
Study objectives	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(s)	Southampton and SW Hampshire REC (A) approved on the 12th May 2009 (ref: 09/H0502/57)
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2009
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Planned sample size: 1300
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Emergency Department

Portsmouth
PO3 6LY
United Kingdom

Sponsor information

Portsmouth Hospitals NHS Trust (UK)
Hospital/treatment centre

Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom

Website	http://www.porthosp.nhs.uk/
"ROR"	https://ror.org/009fk3b63

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

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