Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
09/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes