Condition category
Musculoskeletal Diseases
Date applied
30/06/2010
Date assigned
30/06/2010
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.leeds.ac.uk/medicine/FASTER/

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 measures

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

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

http://www.leeds.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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