Condition category
Musculoskeletal Diseases
Date applied
19/09/2018
Date assigned
21/09/2018
Last edited
11/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Foot pain is common and causes poor balance, falls and difficulty performing everyday activities. Our previous research shows that patients are often frustrated when they see their GP about their feet; ‘They say “well, it’s just arthritis and old age and just keep popping the pills’”. Foot pain is commonly caused by osteoarthritis (OA) in older people, yet compared with other commonly affected joints such as the knee, hip and hand, there has been much less research on the foot. Most existing foot OA research is limited by focussing on the big toe, ignoring symptoms such as pain, and being undertaken in hospital settings. In our previous study, we sent questionnaires to everyone aged over 50 years registered with four general practices, ensuring our findings are relevant to the majority of people living in the community with painful foot OA. We provided the first estimate of how common painful foot OA affecting the big toe and midfoot is. However, it is not known how often painful foot OA gets worse over time, who is likely to do well or badly, or whether seeing a GP or having treatment such as physiotherapy reduces foot pain and improves function over time. Seven-year follow-up of our existing study of foot pain and OA using questionnaires will: (i) describe for the first time how often foot pain and OA get worse over time, (ii) identify which people are going to do well and understand better why some people get worse and (iii) examine whether seeing a GP or having treatments affects foot pain and function over time. This will help understand how to avoid, slow and treat progressive foot OA, understand which patients might respond to treatment, show us new directions for treatment, and improve health services for people with painful foot OA.

Who can participate?
This study is a follow-up of participants who have taken part at previous stages. The participants who will be invited to take part will be individuals who completed a postal Health Questionnaire at baseline, who provided written informed consent to further contact at baseline and at 3 years, who provided further written informed consent to further contact and who have not subsequently withdrawn this
consent.

What does the study involve?
Participants will be mailed a study information pack containing an invitation letter, a Patient Information Sheet, a Questionnaire and a pre-paid addressed envelope. We will invite participants to complete the questionnaire and return it to us in the pre-paid envelope.

What are the possible benefits and risks of participating?
Although direct benefit for participants is unlikely, we hope that what we learn from the study will lead to better management and patient care and help to inform how best to treat people with joint pain in the future. We do not envisage there to be any significant risks.

Where is the study run from?
The Research Institute for Primary Care and Health Sciences, Keele University

When is the study starting and how long is it expected to run for?
October 2018 to March 2019

Who is funding the study?
The National Institute for Health Research - School for Primary Care Research

Who is the main contact?
Michelle Marshall, Research Institute for Primary Care and Health Sciences, Keele University m.marshall@keele.ac.uk

Trial website

https://www.keele.ac.uk/pchs/research/osteoarthritisandosteoporosis/casf/

Contact information

Type

Scientific

Primary contact

Dr Michelle Marshall

ORCID ID

http://orcid.org/0000-0001-8163-6948

Contact details

Research Institute for Primary Care and Health Sciences
Keele University
Keele
Staffordshire
Keele
ST5 5BG
United Kingdom
01782734872
m.marshall@keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG-0278-18 v1.0 25-Jul-2018

Study information

Scientific title

Long-term outcome of foot pain and osteoarthritis in older people. A prospective observational study of foot pain and foot osteoarthritis in the general population: The Clinical Assessment Study of the Foot (CASF) seven-year follow-up.

Acronym

CASF 7-year follow-up

Study hypothesis

The overall aim of this study is to investigate the long−term course of foot pain and foot osteoarthritis over 7 years in community-dwelling adults aged 50 years and over.

The main objectives of the 7-year follow-up of foot pain and OA in a community-dwelling population are:
1. to describe how often foot pain and OA get worse over time
2. to identify which people are going to do well and understand better why some people get worse
3. to examine whether seeing a GP or having treatments affects foot pain and function over time

Ethics approval

East Midlands - Leicester South Research Ethics Committee; 21/08/2018, 18/EM/0249

Study design

Single-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Foot pain, foot osteoarthritis

Intervention

A follow-up postal questionnaire at 7 years for all participants. The questionnaire content will be similar to that used in the CASF study at baseline and 3 years and will be divided into four main sections:
1. General health, psychosocial factors, and social participation
2. Specific health problems including comorbidities
3. Musculoskeletal problems and the presence, duration, location, severity, and impact of foot pain
4. Demographic and socioeconomic characteristics, current employment status and self-reported consultation of GP, and NHS and private physiotherapy, podiatry and chiropody services.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Impact of foot pain assessed using Manchester Foot Pain and Disability Index at 7 years

Secondary outcome measures

1. Foot pain location identified using the Garrow foot manikin
2. Foot pain duration
3. Foot pain intensity assessed using a numerical rating scale (NRS)
4. Foot pain persistence assessed using number of days with pain
5. Foot pain severity assessed using the Chronic Pain Grade Scale (CPGS)
6. Symptom satisfaction using questions adapted from the instrument by Cherkin 1996.
7. Self-reported consultations for foot pain in past 7 years
8. Self-reported treatments and service for foot pain in past 7 years
9. General health assessed using the Short Form-12 (SF-12) health survey
10. Physical functioning assessed using the Short Form-36 (SF-36) health survey
11. Participation restriction assessed using the Keele Assessment of Participation questionnaire
12. Anxiety and depression using the Hospital Anxiety and Depression Scale
13. Body pain location identified using a manikin
14. Self-reported co-morbidities
15. Presence, side and duration of hand, knee and hip pain assessed using single-item questions in the questionnaire
All outcomes will be assessed at 7 years.

Overall trial start date

01/04/2018

Overall trial end date

31/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Registered with one of the four participating local general practices
2. Aged 50 years and over at the time of baseline survey
3. Member of the cohort who completed a postal Health Questionnaire at baseline and provided written informed consent to further contact at baseline
4. At 3 years provided further written informed consent to further contact and has not subsequently withdrawn this consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2212

Participant exclusion criteria

1. Died since last follow-up (3 years for survey cohort participants or 54 months for clinic cohort participants)
2. Departures since the last follow-up (survey cohort only, 3 years for survey cohort)
3. Became unable to complete brief questionnaire or inappropriate to invite to take part – e.g. significant cognitive impairment, dementia, severe/terminal illness, as judged by their GP prior to mailing.

Recruitment start date

01/10/2018

Recruitment end date

04/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Research Institute for Primary Care & Health Sciences
Keele University
Keele, Staffordshire
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University

Sponsor details

Directorate of Engagement & Partnerships
Innovation Centre 2
Keele University
Keele
Staffordshire
ST5 5NH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

NIHR School for Primary Care Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study will be disseminated at high profile national (British Geriatrics Society, UK College of Podiatry) and international (e.g. American College of Rheumatology (ACR), Osteoarthritis Research Society International (OARSI)) conferences and through publication in high-quality peer-review journals (e.g. Journal of Gerontology, Annals of the Rheumatic Diseases). In addition, the Arthritis Research UK Primary Care Centre has a commitment to local dissemination through formal reports, presentations, social media use and newsletters to clinical commissioners, practices and participants. Other forms of dissemination include national Best Practice Days held at the Centre at Keele University annually, articles on the Research Institute’s website, leaflets and posters for general practices, podiatry and physiotherapy clinics, and presentations to community groups and health service commissioners and providers.

We also want to work with our existing Advisory Research User Group to consider additional ways of disseminating findings beyond the traditional academic routes including more patient-focused outlets such as through local radio or newspapers, Twitter, Blogs and Podcasts.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request through liaison with Michelle Marshall; Research Institute for Primary Care and Health Sciences, Keele University; m.marshall@keele.ac.uk. The Research Institute for Primary Care & Health Sciences, in collaborations with Keele CTU, has established data sharing arrangements to support joint publications and other research collaborations. Applications for access to anonymised research datasets are reviewed by the centre’s Data Custodian and Academic (DCAP) Committee to new analysis being proposed. A decision regarding access to the data is made subject to Health Research (HRA) approval first provided for the study, the permissions set by the study sponsor, study funder and in accordance with Data Protection and Research Governance procedures.

Intention to publish date

01/04/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/02/2019: The intention to publish date was changed from 01/04/2019 to 01/04/2020. 15/01/2019: The recruitment end date was changed from 31/12/2018 to 04/01/2019. 20/09/2018: This is a follow-up study to CAS-F (ISRCTN32588605).