Skip to content

Developing a prognostic tool for sprained ankles - the SPRAINED study

Synthesising a clinical Prognostic Rule for Ankle Injuries in the Emergency Department

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12726986
Enrollment
675
Registered
2015-04-30
Start date
2015-06-01
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle sprain Injury, Occupational Diseases, Poisoning

Interventions

In this validation study, we will recruit 675 adult patients with ankle sprains and follow these patients up by questionnaire at set time points over 9 months. We believe poor recovery means serious p

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 16 years or above 3. Diagnosed with acute ankle sprain (<7 days old)

Exclusion criteria

Exclusion criteria: 1. Ankle fracture (excluding flake fracture <2mm) 2. Other recent (<3 months) lower limb fracture

Design outcomes

Primary

MeasureTime frame
A composite measure indicating poor outcome for participants at 9 months, defined as either moderate/severe pain and/or moderate/severe functional difficulty and/or significant lack of confidence in the ankle and/or recurrent sprain.

Secondary

MeasureTime frame
1. Foot and Ankle Outcome Score (FAOS) 2. EuroQuol EQ-5D-3L 3. Health service resource use items

Countries

United Kingdom

Contacts

Public ContactDaryl Hagan
sprained@ndorms.ox.ac.uk01865 228 368

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026