Effect of custom orthoses on foot pain and plantar pressure in pes cavus

ISRCTN	ISRCTN84913516
DOI	https://doi.org/10.1186/ISRCTN84913516
Protocol serial number	N/A
Sponsor	The University of Sydney - School of Physiotherapy (Australia)
Funder	Prescription Foot Orthotic Laboratory Association, Australian Podiatry Education and Research Foundation, New South Wales Podiatrists Registration Board

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Joshua Burns
Scientific

School of Physiotherapy
The University of Sydney
P.O. Box 170
Lidcombe, NSW
1825
Australia

Phone	+61 (0)2 8230 1131
Email	jbur2522@mail.usyd.edu.au

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Foot pain
Key secondary outcome measure(s)	Disability
Completion date	31/05/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	154
Key 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.
Key exclusion criteria	Use of ankle-foot-orthoses (AFO) and pregnancy.
Date of first enrolment	01/12/2003
Date of final enrolment	31/05/2005

School of Physiotherapy

Lidcombe, NSW
1825
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2006		Yes	No