Causes and treatments in mechanically induced foot pain

ISRCTN	ISRCTN77862746
DOI	https://doi.org/10.1186/ISRCTN77862746
Secondary identifying numbers	6050

Submission date: 30/06/2010
Registration date: 30/06/2010
Last edited: 06/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

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

Study website

Contact information

Mrs Jill Halstead
Scientific

Section of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom

Email	j.halstead-rastrick04@leeds.ac.uk

Study information

Study design	Single-centre randomised interventional screening and treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Pathological processes and candidate interventions in mechanically induced foot pain: a single centre randomised interventional screening and treatment trial
Study acronym	PainFoot
Study objectives	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
Ethics approval(s)	1. South Humber Research Ethics Committee, 17/03/2009 2. Amendments approved by Leeds West Research Ethics Committee, 02/06/2010, ref: 09/H1305/10
Health condition(s) or problem(s) studied	Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention	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
Intervention type	Other
Primary outcome measure	Pain scores (VAS) measured at baseline, 6 weeks and 12 weeks
Secondary outcome measures	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
Overall study start date	29/05/2009
Completion date	01/01/2011

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 120, UK sample size: 120
Key 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
Key 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
Date of first enrolment	29/05/2009
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Chapel Allerton Hospital

Leeds
LS7 4SA
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Arthritis Research UK (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

06/09/2016: No publications found, verifying study status with principal investigator.