Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Jill Halstead
ORCID ID
Contact details
Section of Musculoskeletal Disease
2nd Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
-
j.halstead-rastrick04@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6050
Study information
Scientific title
Pathological processes and candidate interventions in mechanically induced foot pain: a single centre randomised interventional screening and treatment trial
Acronym
PainFoot
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
Ethics approval
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
Study design
Single-centre randomised interventional screening and treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
29/05/2009
Overall trial end date
01/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 120, UK sample size: 120
Participant 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
Recruitment start date
29/05/2009
Recruitment end date
01/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Chapel Allerton Hospital
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Research UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list