Contact information
Type
Scientific
Primary contact
Dr Matthew Cooke
ORCID ID
Contact details
School of Health & Social Studies
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 024 76 575850
m.w.cooke@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 01/14/10
Study information
Scientific title
A randomised controlled trial to estimate the clinical and cost-effectiveness of four different methods of mechanical support in severe ankle sprains
Acronym
CAST
Study hypothesis
To estimate:
1. The clinical effectiveness of three different methods of ankle support (below knee plaster cast, Kendall ankle support, Bledsoe boot) in comparison to Tubigrip in the recovery of mobility and function after Grade II and III sprains of the ankle joint.
2. The cost-effectiveness of the three different methods of ankle support in comparison to Tubigrip only. The economic analysis will be conducted from a societal perspective.
Tubigrip has been chosen as the reference (status quo) treatment; it is the cheapest, but is likely to be least effective (ref 1). The Bledsoe boot is a factor of 30 times more expensive (US$50 usual, assuming no re-use), and its clinical effectiveness is yet to be proven. The below knee plaster cast will be Scotch Cast (cost £5). There are a range of ankle supports available. We have selected the Kendall Gel Brace (£19 per brace), which is the cheapest and, in our experience is as clinically effective as other brands. All treatments will be provided in the NHS, in a manner consistent with current national practice.
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
Injury, occupational diseases, poisoning: Musculoskeletal injury
Intervention
1. Below knee plaster cast
2. Kendall ankle support
3. Bledsoe boot
4. Tubigrip
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
18/11/2002
Overall trial end date
17/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with Grade II and III sprains of the ankle joint.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
650
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
18/11/2002
Recruitment end date
17/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health & Social Studies
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
Basic results (scientific)
Publication list
1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15777484
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19217992
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20807469
4. 2020 case study results in ncbi.nlm.nih.gov/pubmed/31937341 (added 16/01/2020)
Publication citations
-
Protocol
Lamb SE, Nakash RA, Withers EJ, Clark M, Marsh JL, Wilson S, Hutton JL, Szczepura A, Dale JR, Cooke MW, , Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450]., BMC Musculoskelet Disord, 2005, 6, 1, doi: 10.1186/1471-2474-6-1.
-
Results
Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A, Underwood M, , A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial., Health Technol Assess, 2010, 14, 41, 1-253, iii-iv, doi: 10.3310/hta14410.
-
Lamb SE, Marsh JL, Hutton JL, Nakash R, Cooke MW, , Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial., Lancet, 2009, 373, 9663, 575-581, doi: 10.1016/S0140-6736(09)60206-3.