Rheumatoid ArthritisCAP-RANCT04515589
Central Aspects of Pain in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study seeks to measure the psychometric properties of a newly developed Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with Rheumatoid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 95 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include people with Rheumatoid Arthritis receiving care at the Kings Mill Hospital, Sherwood Forest NHS Foundation Trust, Nottinghamshire, UK, who meet the eligibility criteria.
Who may be able to join
- Adult (age≥18y) of any sex and ethnicity.
- Satisfy EULAR criteria for RA.
- Active RA, as defined as DAS28 ≥3.2 at baseline visit
Who cannot join
- Unable to give informed consent.
- Insufficient understanding of spoken or written English to comply with the requirements of the study protocol
- Unable or unlikely to complete the proposed 12-week study follow up (eg. moving house, terminal diagnosis, current or planned pregnancy).
- Active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring changes in medical treatment at baseline
- Major active psychiatric condition (e.g. major depression)
- Inability to meet the requirements of clinical assessments
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire
About this study
This study seeks to measure the psychometric properties of a newly developed Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with Rheumatoid Arthritis (RA).
Read the detailed description
Persistent pain and fatigue are prevalent and disabling symptoms in people with Rheumatoid Arthritis, even in the absence of active inflammation. The investigators believe that these symptoms may be a result of abnormal pain processing by the Central Nervous System (CNS), in a process called central sensitization.
The investigators have developed a short, self-report questionnaire to measure central pain mechanisms in people with RA. It is called Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA), and was adapted from a pre-existing questionnaire called CAP-Knee (which measures central sensitization in people with chronic knee pain).
This study aims to measure the psychometric properties of CAP-RA, and the ability of the questionnaire to predict worse pain in the RA population. Secondary objectives of the study include predicting worse fatigue in people with RA, deriving CAP-RA scoring recommendations, investigating other factors associated with persistent RA pain, the association between central sensitization and pain, and investigating the course of pain and fatigue in RA.
Participants will be recruited from a Rheumatology clinic. At baseline and 12 weeks these participants will undergo quantitative sensory testing (QST, pain tests), ultrasound for synovitis, clinical assessments, laboratory tests for systemic inflammation and, complete a questionnaire booklet, including the CAP-RA questionnaire.
Some participants will complete the CAP-RA questionnaire 1 week after the baseline visit to assess the test-retest reliability of the questionnaire.
In addition, participants will provide weekly pain and fatigue self-report via text message (SMS) for 12 weeks.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Pain, Fatigue, Central Sensitization
- Medical subject headings
- Arthritis, Rheumatoid, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main study cohort | The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of CAP-RA
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain.
Measured: Baseline
Psychometric properties of CAP-RA
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain
Measured: 1 week test-retest
Bodily pain
Numerical Rating Scale (0-10) of bodily pain - increasing severity
Measured: 12 weeks
Secondary outcomes (14)
Quantitative Sensory Testing
Validation of CAP-RA as a measure of central sensitization. Lower pressure pain detection thresholds indicate greater sensitivity to painful stimulation. Higher temporal summation indicates dysfunctional pain response. Higher conditioned pain modulation indicates more dysfunctional pain response.
Measured: Baseline
Quantitative Sensory Testing
Validation of CAP-RA as a measure of central sensitization. Lower pressure pain detection thresholds indicate greater sensitivity to painful stimulation. Higher temporal summation indicates dysfunctional pain response. Higher conditioned pain modulation indicates more dysfunctional pain response.
Measured: 12 weeks
Fatigue
Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue.
Measured: 12 weeks
Change and trajectory of bodily pain
Responses to mobile phone text messages giving 0-10 pain scores.
Measured: 12 weeks
Change and trajectory of fatigue
Responses to mobile phone text messages giving 0-10 fatigue scores
Measured: 12 weeks
Physical activity
International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity.
Measured: 12 weeks
Functional status
Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability.
Measured: 12 weeks
Neuropathic pain mechanisms
PainDETECT. Higher scores indicating greater neuropathic pain mechanisms.
Measured: 12 weeks
Mental health
Hospital Anxiety and Depression Scale (HADS) - depression and anxiety. Higher scores indicating worse feelings of anxiety and lower mood.
Measured: 12 weeks
Central sensitization
Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation.
Measured: 12 weeks
Joint inflammation
Ultrasound assessment showing synovitis
Measured: 12 weeks
Swollen joints
Swollen joint count (0-28)
Measured: 12 weeks
Inflammation-Erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm per hour)
Measured: 12 weeks
Inflammation-CRP
High sensitivity C-reactive protein
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start11 Aug 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis, Pfizer
- Responsible party
- Sponsor
- Investigators
- David A Walsh, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515589
- Sponsor's protocol ID
- 20001
- Acronym
- CAP-RA
- Status last verified
- Nov 2023
- First submitted
- 6 Aug 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pre-planned analyses will be performed by the study team. Requests for collaborative analyses of IPD, using non-identifiable data, may be made to the study PI.
Publications
Ifesemen OS, McWilliams DF, Ferguson E, Wakefield R, Akin-Akinyosoye K, Wilson D, Platts D, Ledbury S, Walsh DA. Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA): protocol for a prospective observational study. BMC Rheumatol. 2021 Jun 24;5(1):23. doi: 10.1186/s41927-021-00187-2.
PubMed 34162435
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Aspects of Pain in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04515589
- Acronym / sponsor ID
- CAP-RA / 20001
- Conditions
- Rheumatoid Arthritis
- Keywords
- Pain, Fatigue, Central Sensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Versus Arthritis, Pfizer
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to measure the psychometric properties of a newly developed Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with Rheumatoid Arthritis (RA).
Detailed description
Persistent pain and fatigue are prevalent and disabling symptoms in people with Rheumatoid Arthritis, even in the absence of active inflammation. The investigators believe that these symptoms may be a result of abnormal pain processing by the Central Nervous System (CNS), in a process called central sensitization.
The investigators have developed a short, self-report questionnaire to measure central pain mechanisms in people with RA. It is called Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA), and was adapted from a pre-existing questionnaire called CAP-Knee (which measures central sensitization in people with chronic knee pain).
This study aims to measure the psychometric properties of CAP-RA, and the ability of the questionnaire to predict worse pain in the RA population. Secondary objectives of the study include predicting worse fatigue in people with RA, deriving CAP-RA scoring recommendations, investigating other factors associated with persistent RA pain, the association between central sensitization and pain, and investigating the course of pain and fatigue in RA.
Participants will be recruited from a Rheumatology clinic. At baseline and 12 weeks these participants will undergo quantitative sensory testing (QST, pain tests), ultrasound for synovitis, clinical assessments, laboratory tests for systemic inflammation and, complete a questionnaire booklet, including the CAP-RA questionnaire.
Some participants will complete the CAP-RA questionnaire 1 week after the baseline visit to assess the test-retest reliability of the questionnaire.
In addition, participants will provide weekly pain and fatigue self-report via text message (SMS) for 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study cohort | – | –The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include people with Rheumatoid Arthritis receiving care at the Kings Mill Hospital, Sherwood Forest NHS Foundation Trust, Nottinghamshire, UK, who meet the eligibility criteria.
Key inclusion criteria (3 listed)
- Adult (age≥18y) of any sex and ethnicity.
- Satisfy EULAR criteria for RA.
- Active RA, as defined as DAS28 ≥3.2 at baseline visit
Key exclusion criteria (6 listed)
- Unable to give informed consent.
- Insufficient understanding of spoken or written English to comply with the requirements of the study protocol
- Unable or unlikely to complete the proposed 12-week study follow up (eg. moving house, terminal diagnosis, current or planned pregnancy).
- Active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring changes in medical treatment at baseline
- Major active psychiatric condition (e.g. major depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychometric properties of CAP-RA
Time frame: Baseline
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain.
Psychometric properties of CAP-RA
Time frame: 1 week test-retest
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain
Bodily pain
Time frame: 12 weeks
Numerical Rating Scale (0-10) of bodily pain - increasing severity
14 secondary outcomes
Quantitative Sensory Testing
Time frame: Baseline
Quantitative Sensory Testing
Time frame: 12 weeks
Fatigue
Time frame: 12 weeks
Change and trajectory of bodily pain
Time frame: 12 weeks
Change and trajectory of fatigue
Time frame: 12 weeks
Physical activity
Time frame: 12 weeks
Functional status
Time frame: 12 weeks
Neuropathic pain mechanisms
Time frame: 12 weeks
Mental health
Time frame: 12 weeks
Central sensitization
Time frame: 12 weeks
Joint inflammation
Time frame: 12 weeks
Swollen joints
Time frame: 12 weeks
Inflammation-Erythrocyte sedimentation rate
Time frame: 12 weeks
Inflammation-CRP
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 34162435Ifesemen OS, McWilliams DF, Ferguson E, Wakefield R, Akin-Akinyosoye K, Wilson D, Platts D, Ledbury S, Walsh DA. Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA): protocol for a prospective observational study. BMC Rheumatol. 2021 Jun 24;5(1):23. doi: 10.1186/s41927-021-00187-2.
- Individual participant dataSharing planned: Undecided. Pre-planned analyses will be performed by the study team. Requests for collaborative analyses of IPD, using non-identifiable data, may be made to the study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Walsh principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric properties of CAP-RA (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.