Topic: Musculoskeletal
Conditions
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 functi
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain scores (VAS) measured at baseline, 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed