Pain and its management in patients with inflammatory arthritis

ISRCTN	ISRCTN39709888
DOI	https://doi.org/10.1186/ISRCTN39709888
IRAS number	311575
Secondary identifying numbers	CPMS 52587, NIHR300826, IRAS 311575

Submission date: 13/02/2023
Registration date: 25/04/2023
Last edited: 20/08/2024

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

Background and study aims
Inflammatory arthritis refers to conditions causing joint pain and swelling. The commonest conditions are rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axial SpA).
Despite the availability of powerful medicines that treat joint inflammation, many people with inflammatory arthritis suffer from daily pain. This can be life-changing for them.
Strong pain medicines like “opioids” are often prescribed to people with inflammatory arthritis, despite limited evidence that they help arthritis pain, and many potential side effects.
Studies have shown that non-drug treatments like exercise can help inflammatory arthritis pain. Little is known about how often they are used, although one survey of people with rheumatoid arthritis reported that half of people could not access all the non-drug treatments they required.
There is an urgent need to improve NHS pain care for people with inflammatory arthritis. The first step to achieving this is to understand how pain is currently treated. The PAIN PATH Studies will do this by answering several questions, including:
1. What pain care do people with inflammatory arthritis receive?
2. Do all people with inflammatory arthritis receive the same pain care?
3. How often do people with inflammatory arthritis use pain medicines?

Who can participate?
Aged 18 years or older, with a diagnosis of RA, PsA or axial SpA.

What does the study involve?
Two studies will be undertaken. Study 1 (“PAIN PATH Survey”) involves people with inflammatory arthritis completing a questionnaire assessing their pain care. Study 2 (“PAIN PATH Longitudinal Study”) involves people with inflammatory arthritis answering mobile phone text messages (twice a day for 14 days) or entering information into an online NHS system (once a week for 3 months) to understand how they use their pain medicines.

What are the possible benefits and risks of participating?
We will provide participants using the PAIN PATH Portal for data entry with anonymised summaries of their research data, which they may find helpful for monitoring their health over time. We intend to use the research findings to improve pain care in patients with inflammatory arthritis in the NHS, which would potentially benefit participants in the studies in the longer term.

Where is the study run from?
Keele University (UK)

When is the study starting and how long is it expected to run for?
March 2021 to March 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Dr Ian Scott, i.scott@keele.ac.uk

Contact information

Dr Ian Scott
Principal Investigator

School of Medicine
Keele University
Keele
ST5 5BG
United Kingdom

ORCID ID	0000-0002-1268-9808
Email	i.scott@keele.ac.uk

Study information

Study design	Observational cross-sectional
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Community, GP practice, Home, Hospital
Study type	Other
Participant information sheet	43207 IRAS 311575_PAIN PATH National PIS_v1.0_17Mar22.pdf
Scientific title	PAIN and its management in PAtients with inflammatory arTHritis: the PAIN PATH Survey and Longitudinal Study.
Study acronym	PAIN PATH
Study hypothesis	Survey: 1. Define the current pain experience of patients with inflammatory arthritis (IA) and examine whether this associates with patients’ IA subtype, age, gender, ethnicity, socioeconomic status, comorbidity, and geographical region. 2. Describe the delivery of pain care in patients with IA against EULAR guidance and assess potential inequities in this by testing associations between the receipt of core recommended pain care and IA subtypes, age, gender, ethnicity, socioeconomic status, comorbidity, and geographical region. 3. Evaluate analgesic use in patients with IA and examine its relationship with patients’ beliefs about the necessity and harms of their pain medicines. Longitudinal Study: 1. Describe the frequency and patterns of analgesic use in patients with IA and examine how the frequency varies by (a) patient characteristics (age, sex, ethnicity), (b) the presence of fibromyalgia, depression, and anxiety, (c) patients’ beliefs about the necessity and harms of medicines, and (d) IA subtypes. 2. Examine potential drivers of analgesic use in patients with IA, by (a) describing the frequency of self-reported triggers, and (b) evaluating the relationship between analgesic use and pain intensity and disease activity. 3. Compare the frequency of analgesic use and pain intensity levels in patients with IA that self-report using analgesics on a time-scheduled vs. pain-contingent basis.
Ethics approval(s)	Approved 04/05/202, North East - Newcastle & North Tyneside 2 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 207 1048091; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 22/NE/0071
Condition	Inflammatory arthritis
Intervention	The PAIN PATH survey involves patients with inflammatory arthritis completing a one-off questionnaire online (or alternatively on paper for those taking part at their local hospital). The PAIN PATH Longitudinal Study involves patients with inflammatory arthritis reporting information on their pain and pain medicine use over time using short-messaging service (SMS) text messages or an online patient portal. Both studies will include patients that learn about the studies when they see their rheumatology team (“regional recruitment”) or if they see online advertisements (“national recruitment”). Patients will be able to take part in the studies over a 2-year period. It is anticipated that at least 1,800 patients regionally and 1,000 patients nationally will take part in the PAIN PATH Survey, and at least 173 patients regionally and 210 patients nationally will take part in the PAIN PATH Longitudinal Study. Longitudinal study for patients learning about the study from rheumatology team at six West Midlands NHS Trusts (regional recruitment): After completing the questionnaire, if patients indicate they are interested in taking part in the PAIN PATH Longitudinal Study will receive text messages twice a day at 8am and 8pm for 7 days. Seven weeks later this will be repeated. The messages will ask them questions on whether they used pain medicines in the previous 12 hours, the reason they used them, and their worst pain level in the previous 12 hours. Longitudinal study for patients learning about the study online (national recruitment): Patients will be asked to enter research information into the Portal once a week for 3 months, starting in the week after Portal registration.
Intervention type	Other
Primary outcome measure	PAIN PATH survey questionnaire completed at a single time point: 1. Pain severity – evaluated using the simplified Graded Chronic Pain Scale Revised (GCPS-R), measured in the regional/national survey at NHS sites or on paper/online by the participant. 2. Fibromyalgia – its presence or absence will be established using the Widespread Pain Index and Symptom Severity Score, allowing diagnostic criteria to be applied measured in the regional/national survey at NHS sites or on paper/online by the participant. 3. Pain trajectories – the Visual Trajectories Questionnaire-Pain (VTQ-P) will ask patients to classify their pain experience into one of a number of trajectories using visual and word descriptions. measured in the regional/national survey at NHS sites or on paper/online by the participant. 4. Pain Assessments-n As EULAR guidelines recommend a broad range of pain assessment components it is unfeasible to assess all of these within the questionnaire. We therefore prioritized the following for evaluation, which represent core aspects of pain assessments: 5.1. assessment of pain severity. 5.2. invitation for patients to disclose the impact of pain on their daily functioning. 5.3. assessment of patients’ ideas and concerns regarding the cause of their pain. 5.4. consideration of patients’ expectations for treatment. 5.5. consideration of patients’ preferences for treatment. 5.6. assessment of previous pain treatments and their effects. 5.7. assessment of pain-related factors that may need attention (questions 2H, considering mood, and 2I, considering sleep). 5. Pain Management - A further series of bespoke questions developed for this survey will assess pain management against EULAR guidelines measured in the regional/national survey at NHS sites or on paper/online by the participant. 6. The Beliefs About Medicines Questionnaire (BMQ) will evaluate patients’ beliefs about their pain medicines measured in the regional/national survey at NHS sites or on paper/online by the participant. 7. Patient global assessment of arthritis activity measured in the regional/national survey at NHS sites or on paper/online by the participant. 8. Patients with an axial spondyloarthritis will also be asked to complete questions from the BASDAI measured in the regional/national survey at NHS sites or on paper/online by the participant. 9. Patients will be asked to complete the functional questions from the multidimensional Health Assessment Questionnaire (mdHAQ) measured in the regional/national survey at NHS sites or on paper/online by the participant. 10. Generalised Anxiety Disorder 2-Item (GAD-2) measured in the regional/national survey at NHS sites or on paper/online by the participant. 11. Patient Health Questionnaire 2-Item (PHQ-2) measured in the regional/national survey at NHS sites or on paper/online by the participant. 12. The single-item physical activity measure will evaluate physical activity levels in the last week measured in the regional/national survey at NHS sites or on paper/online by the participant. 13. Patients will be asked whether they have any of the comorbidities included in the Rheumatic Disease Comorbidity Index measured in the regional/national survey at NHS sites or on paper/online by the participant. 14. Patients will be asked their year of IA diagnosis, which DMARDs they are currently receiving, and if they have received intramuscular steroids in the last month measured in the regional/national survey at NHS sites or on paper/online by the participant. 15. Patients will be asked to record their ethnicity (using groupings advocated by the Office for National Statistics), date of birth, sex at birth, height, weight, postcode, and employment status measured in the regional/national survey at NHS sites or on paper/online by the participant. Pain Path Longitudinal study: Regional Recruitment The day after completing the PAIN PATH survey and consenting to take part, patients will receive SMS messages twice daily at 8am and 8pm for 7 days. Seven weeks later the process will be repeated. They allow analgesic use and pain intensity to be captured from two time-periods: (a) Daytime (8am to 8pm; Figure 5); (b) Night-time (8pm to 8am) Pain Path Longitudinal study: National Recruitment The following data will be captured each week on an NHS online portal developed by Midlands Partnership NHS trust, patients will be asked to make a research data entry once a week for 3 months: 1. Average pain intensity score in the last week on an 11-point numeric rating scale with the anchors “no pain” and “pain as bad as you can imagine”. 2. Which analgesic(s) they used in the last week (from a pre-specified list) 3. Frequency of analgesic use in the last week for tablets/capsules, topical NSAIDs, and pain patches. 4. Reason(s) they used analgesics (unless no analgesics used): they can choose multiple pre-specified options (with the reasons as per those for the SMS messages) and enter a free-text reason. The following additional data will be captured every 2 weeks: 5. Disease activity 5.1. all patients will be asked to complete a patient global assessment of arthritis activity on an 11-point NRS. 5.2. Patients with RA and peripheral PsA will be asked to perform self-reported swollen and tender joint counts. 5.3. Patients with an axial SpA will be asked to complete a BASDAI. 6. Function – all patients will complete the functional scale from the mdHAQ. 7. Sleep – all patients will complete the sleep item from the mdHAQ. 8. Mental health – all patients will complete the PHQ-2 and GAD-2.
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	01/03/2021
Overall study end date	18/03/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 1800; UK Sample Size: 1800
Participant inclusion criteria	REGIONAL RECRUITMENT For both studies, patients will be included that are: 1. Aged >= 18 years 2. Have a clinical diagnosis of RA, PsA or axial SpA 3. Provide consent. Additionally, for the longitudinal study patients will be included that: 1. Have completed the PAIN PATH Survey 2. Have mobile-phone access 3. Currently use an analgesic that can be taken at least twice a day (as per their understanding of their prescription) 4. Report currently using analgesics at least once a week (to allow drivers of analgesic use to be examined). NATIONAL RECRUITMENT For both studies, patients will be included that are: 1. Aged >= 18 years 2. Have a self-reported diagnosis of RA, PsA or axial SpA 3. Provide consent 4. Have internet access and an email address, and (e) receive care in one of the UK National Health Services. Additionally, for the longitudinal study patients will be included that: 1. Have completed the PAIN PATH Survey 2. Report using analgesics in the last month
Participant exclusion criteria	1. For both studies those patients who enroll via the national recruitment pathway will not also be able to participate in the regional study (and vice versa) to avoid people taking part in the study on more than one occasion. 2. For the longitudinal study the SMS-messages and Portal have questions that are written in English, which are answered remotely on multiple occasions. Consequently, patients who cannot respond to written English themselves, and are unable to access translation support from a relative, friend or carer, will not be able to participate.
Recruitment start date	18/07/2022
Recruitment end date	10/09/2024

Locations

Countries of recruitment

England
Northern Ireland
Scotland
United Kingdom
Wales

Study participating centres

Midlands Partnership NHS Foundation Trust

Trust Headquarters
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust

Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

The Royal Wolverhampton NHS Trust

New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Sandwell and West Birmingham Hospitals NHS Trust

City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

The Dudley Group NHS Foundation Trust

Russells Hall Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Gobowen
Oswestry
SY10 7AG
United Kingdom

Sponsor information

Keele University
University/education

Keele Road
Newcastle-under-Lyme
ST5 5BG
England
United Kingdom

Phone	+44 1782 732975
Email	research.governance@keele.ac.uk
Website	http://www.keele.ac.uk/
"ROR"	https://ror.org/00340yn33

Funders

Funder type

Government

NIHR Academy

No information available

Results and Publications

Intention to publish date	31/03/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	We will make all outputs from this work widely and freely available to all stakeholders, in ways that are easy to access at no cost. In addition to publication in open-access journals, we will use Keele University’s website and social media, and dedicated and widely-followed Twitter and Facebook feeds, to support dissemination of the findings.
IPD sharing plan	The current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	National PIS version 1.0	17/03/2022	02/03/2023	No	Yes
Participant information sheet	Regional PIS version 1.0	17/03/2022	02/03/2023	No	Yes

Additional files

43207 IRAS 311575_PAIN PATH Regional PIS_v1.0_17Mar22.pdf: Regional PIS
43207 IRAS 311575_PAIN PATH National PIS_v1.0_17Mar22.pdf: National PIS

Editorial Notes

20/08/2024: The recruitment end date was changed from 18/07/2024 to 10/09/2024.
06/06/2023: Contact details updated.
02/05/2023: Internal review.
13/02/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).