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| [ Print-friendly version ] |
| Causes and treatments in mechanically induced foot pain |
| ISRCTN | ISRCTN77862746 |
| ClinicalTrials.gov identifier | |
| Public title | Causes and treatments in mechanically induced foot pain |
| Scientific title | Pathological processes and candidate interventions in mechanically induced foot pain: a single centre randomised interventional screening and treatment trial |
| Acronym | PainFoot |
| Serial number at source | 6050 |
| Study hypothesis |
Foot pain in healthy individuals is often associated with poor movement and function of the lower limbs. Abnormal function in other joints such as the knees and hands has been shown to be associated with early magnetic resonance imaging (MRI) abnormalities, which in turn can be a precursor to osteoarthritis. The associations between foot pain, patterns of bone/joint swelling on MRI and joint movement analysis have not been previously explored. This study aims to investigate the effects of in-shoe orthotic devices; commonly used to treat foot pain, upon foot movement, symptoms and MRI findings.
Objectives: 1. To identify using MRI, patterns of altered metabolism in the bones of the midfoot and to explore the relationship of these changes to movement characteristics associated with pain in the arch of the foot 2. Investigate the potential for orthoses to change systematically; foot mechanical function, pain and patterns of altered bone metabolism Design: Proof of concept study and clinical investigation with a laboratory and imaging component. Treatment groups: 1. Functional foot orthoses intended to systematically alter foot function 2. Inert cushioning orthoses known to exert minimal effect on the intrinsic function of the foot |
| Lay summary | |
| Ethics approval | South Humber Research Ethics Committee approved on the 17th March 2009. Amendments approved by Leeds West Research Ethics Committee on the 2nd June 2010 (ref: 09/H1305/10). |
| Study design | Single centre randomised interventional screening and treatment trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal |
| Participants - inclusion criteria |
Both groups:
1. Participants aged 18 years and over 2. Both male and female 3. Able to understand and provide informed consent Foot pain group: 3. History of foot pain when weight bearing between 3 and 18 months duration 4. Pain located in the midfoot region 5. Type of pain considered consistent with pain of mechanical origin by an experienced musculoskeletal specialist podiatrist Comparative healthy pain free group: 6. No history of foot pain in the last 24 months 7. Able to walk for 30 minutes without pain or discomfort in any other lower limb joints |
| Participants - exclusion criteria |
Foot pain group:
1. Established OA of the midfoot region 2. Foot surgery in the last 12 months 3. Localised plantar heel pain typical of plantar fasciitis 4. Foot pain typical of undiagnosed inflammatory arthritis inflamed ankle joint complex, bursitis, tenosynovitis, enthesitis 5. A medical history of unstable diabetes mellitus or diabetic complications 6. A medical history of peripheral arterial disease 7. A medical history of systemic inflammatory disease 8. Known pregnancy 9. A medical history of kidney disease 10. A medical history of organ transplantation 11. A patient fitted with a pacemaker or any other implant contra-indicated for magentic resonance imaging (MRI) scanning 12. Recent heart bypass surgery in the last 6 months 13. Currently wearing in-shoe orthoses device 14. A medical history of neurological disorders or positive clinical findings of pedal sensory neuropathy Comparative healthy pain free group: 15. A medical history of unstable diabetes mellitus or diabetic complications 16. A medical history of peripheral arterial disease 17. A medical history of systemic inflammatory disease 18. Known pregnancy 19. A medical history of kidney disease 20. A medical history of organ transplantation 21. A patient fitted with a pacemaker or any other implant contra-indicated for MRI scanning |
| Anticipated start date | 29/05/2009 |
| Anticipated end date | 01/01/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned sample size: 120, UK sample size: 120 |
| Interventions |
Random allocation to one of the following:
1. Functional foot orthoses intended to systematically alter foot function 2. Inert cushioning orthoses known to exert minimal effect on the intrinsic function of the foot Follow-up length: 3 months Study entry: registration and one or more randomisations |
| Primary outcome measure(s) | Pain scores (VAS), measured at baseline, 6 weeks and 12 weeks. |
| Secondary outcome measure(s) |
Measured at baseline, 6 weeks and 12 weeks:
1. Modified Manchester Foot Pain and Disability Questionnaire 2. MRI semi-quantitative and quantitative scores 3. Multi-segment foot kinematics |
| Sources of funding | Arthritis Research UK (UK) |
| Trial website | http://www.leeds.ac.uk/medicine/FASTER/ |
| Publications | |
| Contact name | Mrs Jill Halstead |
| Address |
Section of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital Chapeltown Road |
| City/town | Leeds |
| Zip/Postcode | LS7 4SA |
| Country | United Kingdom |
| j.halstead-rastrick04@leeds.ac.uk | |
| Sponsor | University of Leeds (UK) |
| Address | Woodhouse Lane |
| City/town | Leeds |
| Zip/Postcode | LS2 9JT |
| Country | United Kingdom |
| Sponsor website: | http://www.leeds.ac.uk/ |
| Date applied | 30/06/2010 |
| Last edited | 13/07/2010 |
| Date ISRCTN assigned | 30/06/2010 |
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