Feasibility study to evaluate the clinical and cost effectiveness of foot orthoses in the management of plantar heel pain
| ISRCTN | ISRCTN73264439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73264439 |
| Protocol serial number | RRC300/SG |
| Sponsor | North Tyneside AHA Trust Research Unit (UK) |
| Funder | Department of Health (UK) - Directorate of Health & Social Care |
- Submission date
- 18/12/2002
- Registration date
- 18/12/2002
- Last edited
- 09/10/2007
- 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
Dr Keith Rome
Scientific
Scientific
University of Teesside
School of Health and Social Care
Middlesbrough
TS1 3BA
United Kingdom
| Phone | +44 (0)1642 384977 |
|---|---|
| K.Rome@tees.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Plantar heel pain |
| Intervention | Two types of foot orthoses (based on costs and function) were measured at baseline, 4 and 8 weeks using general (EQ5D), specific (Foot Health Status Questionnaire) outcome measures together with an economic questionnaire |
| 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 | 01/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 48 patients clinically diagnosed with plantar heel pain. The inclusion criteria included the following: 1. Unilateral plantar heel pain of at least 2-months duration 2. A history of night-time or early morning pain, which decreases after walking, and/or increases after exercise or prolonged periods of standing 3. Heel pain severe enough to either cause a reduction in physical activity, a visit to a health professional, or the use of medication 4. Good general health |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Teesside
Middlesbrough
TS1 3BA
United Kingdom
TS1 3BA
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/05/2004 | Yes | No |
