Effect of custom orthoses on foot pain and plantar pressure in pes cavus
| ISRCTN | ISRCTN84913516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84913516 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/03/2005
- Registration date
- 06/05/2005
- Last edited
- 02/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Joshua Burns
Scientific
Scientific
School of Physiotherapy
The University of Sydney
P.O. Box 170
Lidcombe, NSW
1825
Australia
| Phone | +61 (0)2 8230 1131 |
|---|---|
| jbur2522@mail.usyd.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Foot pain |
| Secondary outcome measures | Disability |
| Overall study start date | 01/12/2003 |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Australia
Study participating centre
School of Physiotherapy
Lidcombe, NSW
1825
Australia
1825
Australia
Sponsor information
The University of Sydney - School of Physiotherapy (Australia)
University/education
University/education
P.O. Box 170
Lidcombe, NSW
1825
Australia
"ROR" |
https://ror.org/0384j8v12 |
|---|
Funders
Funder type
Charity
Prescription Foot Orthotic Laboratory Association, Australian Podiatry Education and Research Foundation, New South Wales Podiatrists Registration Board
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |
