Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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

Mr Joshua T Wies

ORCID ID

Contact details

Box 194
Rheumatology Research Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217459

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093555

Study information

Scientific title

Acronym

Study hypothesis

Orthotics treatment of foot and knee pain

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

Treatment

Patient information sheet

Condition

Signs and Symptoms: knee/foot pain

Intervention

Subjects will be referred via specialist orthopaedic and rheumatology clinics and will sign informed consent. They will be assessed by a Chartered Physiotherapist (Kristin Giussani) which will include measurements of strength, range of movement, and outcome measures of pain and function. They will then be fitted with either a real or placebo customised shoe insert (an orthotic) which they will use for a 1-month period. The patient will keep a diary of their pain and function over a 1-month period.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/10/2000

Overall trial end date

21/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40 subjects (PROJ 10/10/2000)

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/10/2000

Recruitment end date

21/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box 194
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (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

Publication citations

Additional files

Editorial Notes