Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, United Kingdom
NCT Number: NCT04515589
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).
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Notify Me18 year and older
All sexes
Observational
Mansfield, Nottinghamshire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain.
Time frame: 1 week test-retest
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain
Time frame: 12 weeks
Numerical Rating Scale (0-10) of bodily pain - increasing severity
Time frame: Baseline
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
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
Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue.
Time frame: 12 weeks
Responses to mobile phone text messages giving 0-10 pain scores.
Time frame: 12 weeks
Responses to mobile phone text messages giving 0-10 fatigue scores
Time frame: 12 weeks
International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity.
Time frame: 12 weeks
Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability.
Time frame: 12 weeks
PainDETECT. Higher scores indicating greater neuropathic pain mechanisms.
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS) - depression and anxiety. Higher scores indicating worse feelings of anxiety and lower mood.
Time frame: 12 weeks
Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation.
Time frame: 12 weeks
Ultrasound assessment showing synovitis
Time frame: 12 weeks
Swollen joint count (0-28)
Time frame: 12 weeks
Erythrocyte sedimentation rate (mm per hour)
Time frame: 12 weeks
High sensitivity C-reactive protein
University of Nottingham
Other
Acronym: CAP-RA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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