Central Aspects of Pain in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT04515589
• Lead Sponsor: University of Nottingham

Brief 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 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 Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-17
• Study Start: 2021-08-11
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Adult (age≥18y) of any sex and ethnicity.
• Satisfy EULAR criteria for RA.
• Active RA, as defined as DAS28 ≥3.2 at baseline visit

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bodily pain	12 weeks	Numerical Rating Scale (0-10) of bodily pain - increasing severity
Psychometric properties of CAP-RA	1 week test-retest	A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain

Secondary Outcome Measures

Name	Time	Method
Swollen joints	12 weeks	Swollen joint count (0-28)
Quantitative Sensory Testing	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.
Fatigue	12 weeks	Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue.
Physical activity	12 weeks	International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity.
Functional status	12 weeks	Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability.
Change and trajectory of bodily pain	12 weeks	Responses to mobile phone text messages giving 0-10 pain scores.
Change and trajectory of fatigue	12 weeks	Responses to mobile phone text messages giving 0-10 fatigue scores
Neuropathic pain mechanisms	12 weeks	PainDETECT. Higher scores indicating greater neuropathic pain mechanisms.
Mental health	12 weeks	Hospital Anxiety and Depression Scale (HADS) - depression and anxiety. Higher scores indicating worse feelings of anxiety and lower mood.
Central sensitization	12 weeks	Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation.
Joint inflammation	12 weeks	Ultrasound assessment showing synovitis
Inflammation-Erythrocyte sedimentation rate	12 weeks	Erythrocyte sedimentation rate (mm per hour)
Inflammation-CRP	12 weeks	High sensitivity C-reactive protein

Trial Locations

Locations (1)

Sherwood Forest Hospitals NHS Foundation Trust; 🇬🇧 Mansfield, Nottinghamshire, United Kingdom