Condition category
Musculoskeletal Diseases
Date applied
29/03/2005
Date assigned
06/05/2005
Last edited
02/10/2008
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 Burns

ORCID ID

Contact details

School of Physiotherapy
The University of Sydney
P.O. Box 170
Lidcombe
NSW
1825
Australia
+61 (0)2 8230 1131
jbur2522@mail.usyd.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Persons with pes cavus commonly report foot pain, but rigorous scientific
evidence for the effectiveness of custom foot orthoses for this condition is lacking. We aimed to determine the efficacy of custom foot orthoses for pes cavus, with respect to pain relief, reduction of disability and
improvement of plantar pressure distribution.

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

Pes cavus

Intervention

Patients are randomised to one of two groups:
1. Group 1 is treated with custom moulded foot orthoses
2. Group 2 is given sham orthoses

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Foot pain

Secondary outcome measures

Disability

Overall trial start date

01/12/2003

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women aged 18 years or older, literate in English to complete health status questionnaires, musculoskeletal foot pain of at least one month duration, bilateral pes cavus and willingness to consent to randomization and study orthoses provisions.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

154

Participant exclusion criteria

Use of ankle-foot-orthoses (AFO) and pregnancy.

Recruitment start date

01/12/2003

Recruitment end date

31/05/2005

Locations

Countries of recruitment

Australia

Trial participating centre

School of Physiotherapy
Lidcombe, NSW
1825
Australia

Sponsor information

Organisation

The University of Sydney - School of Physiotherapy (Australia)

Sponsor details

P.O. Box 170
Lidcombe
NSW
1825
Australia

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Prescription Foot Orthotic Laboratory Association, Australian Podiatry Education and Research Foundation, New South Wales Podiatrists Registration Board

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16707631

Publication citations

  1. Results

    Burns J, Crosbie J, Ouvrier R, Hunt A, Effective orthotic therapy for the painful cavus foot: a randomized controlled trial., J Am Podiatr Med Assoc, 96, 3, 205-211.

Additional files

Editorial Notes