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| Name | Class |
|---|---|
| Versus Arthritis | OTHER |
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main study cohort | The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis |
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| Measure | Description | Time Frame |
|---|---|---|
| Psychometric properties of CAP-RA | A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain. | Baseline |
| Psychometric properties of CAP-RA | A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain | 1 week test-retest |
| Bodily pain | Numerical Rating Scale (0-10) of bodily pain - increasing severity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| David A Walsh | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sherwood Forest Hospitals NHS Foundation Trust | Mansfield | Nottinghamshire | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34162435 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Blood samples
| 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. |
| 12 weeks |
| Fatigue | Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue. | 12 weeks |
| Change and trajectory of bodily pain | Responses to mobile phone text messages giving 0-10 pain scores. | 12 weeks |
| Change and trajectory of fatigue | Responses to mobile phone text messages giving 0-10 fatigue scores | 12 weeks |
| Physical activity | International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity. | 12 weeks |
| Functional status | Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability. | 12 weeks |
| Neuropathic pain mechanisms | PainDETECT. Higher scores indicating greater neuropathic pain mechanisms. | 12 weeks |
| Mental health | Hospital Anxiety and Depression Scale (HADS) - depression and anxiety. Higher scores indicating worse feelings of anxiety and lower mood. | 12 weeks |
| Central sensitization | Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation. | 12 weeks |
| Joint inflammation | Ultrasound assessment showing synovitis | 12 weeks |
| Swollen joints | Swollen joint count (0-28) | 12 weeks |
| Inflammation-Erythrocyte sedimentation rate | Erythrocyte sedimentation rate (mm per hour) | 12 weeks |
| Inflammation-CRP | High sensitivity C-reactive protein | 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |