An observational study in Rheumatoid Arthritis, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University of Nottingham · Observational
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).
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 95 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
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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.
Exclusion Criteria:
The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis
Psychometric properties of CAP-RA
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain.
Time frame: Baseline
Psychometric properties of CAP-RA
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain
Time frame: 1 week test-retest
Bodily pain
Numerical Rating Scale (0-10) of bodily pain - increasing severity
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 12 weeks
Fatigue
Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue.
Time frame: 12 weeks
Change and trajectory of bodily pain
Responses to mobile phone text messages giving 0-10 pain scores.
Time frame: 12 weeks
Change and trajectory of fatigue
Responses to mobile phone text messages giving 0-10 fatigue scores
Time frame: 12 weeks
Physical activity
International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity.
Time frame: 12 weeks
Functional status
Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability.
Time frame: 12 weeks
Neuropathic pain mechanisms
PainDETECT. Higher scores indicating greater neuropathic pain mechanisms.
Time frame: 12 weeks
Mental health
Hospital Anxiety and Depression Scale (HADS) - depression and anxiety. Higher scores indicating worse feelings of anxiety and lower mood.
Time frame: 12 weeks
Central sensitization
Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation.
Time frame: 12 weeks
Joint inflammation
Ultrasound assessment showing synovitis
Time frame: 12 weeks
Swollen joints
Swollen joint count (0-28)
Time frame: 12 weeks
Inflammation-Erythrocyte sedimentation rate
Erythrocyte sedimentation rate (mm per hour)
Time frame: 12 weeks
Inflammation-CRP
High sensitivity C-reactive protein
Time frame: 12 weeks
Plan to share: 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.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Nottingham