Pilot studies of the effects of custom semi-rigid full-foot orthotics on planta-surface foot pain and anterior knee pain: towards evidence-based practice
| ISRCTN | ISRCTN45432551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45432551 |
| Protocol serial number | N0544093555 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Joshua T Wies
Scientific
Scientific
Box 194
Rheumatology Research Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pilot studies of the effects of custom semi-rigid full-foot orthotics on planta-surface foot pain and anterior knee pain: towards evidence-based practice |
| Study objectives | Orthotics treatment of foot and knee pain |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 21/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/10/2000 |
| Date of final enrolment | 21/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box 194
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
21/11/2019: No publications found. All search options exhausted.
