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baseline and at 3 years, who provided further written informed consent to further contact and who have not subsequently withdrawn this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
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
01/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list