| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN73264439 |
| Date ISRCTN assigned | 18/12/2002 |
| Local reference number(s) | RRC300/SG |
| Public title | Feasibility study to evaluate the clinical and cost effectiveness of foot orthoses in the management of plantar heel pain |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Plantar heel pain |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2001 |
| Anticipated end date | 01/01/2002 |
| Status of trial | Completed |
| Target number of participants | 48 |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15153583 |
| Sources of funding | Department of Health (UK) - Directorate of Health & Social Care |
| Sponsor name | North Tyneside AHA Trust Research Unit (UK) |
| Sponsor details | North Tyneside General Hospital
Research Support Unit
Rake Lane
North Shields
United Kingdom
NE29 8NH |
| Contact name | Dr Keith Rome |
| Contact details | University of Teesside
School of Health and Social Care
Middlesbrough
United Kingdom
TS1 3BA |
| Contact telephone | +44 (0)1642 384977 |
| Contact fax | +44 (0)1642 384105 |
| Contact email | K.Rome@tees.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN73264439 |
| Date last extracted from ISRCTN register | 17/04/2008 |
