Clinical trial NCT04515589: Central Aspects of Pain in Rheumatoid Arthritis
Official title: Central Aspects of Pain in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Pain
Fatigue
Central Sensitization
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Versus Arthritis
name: Pfizer
First posted: 2020-08-17
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychometric properties of CAP-RA
timeFrame: Baseline
measure: Psychometric properties of CAP-RA
timeFrame: 1 week test-retest
measure: Bodily pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Quantitative Sensory Testing
timeFrame: Baseline
measure: Quantitative Sensory Testing
timeFrame: 12 weeks
measure: Fatigue
timeFrame: 12 weeks
measure: Change and trajectory of bodily pain
timeFrame: 12 weeks
measure: Change and trajectory of fatigue
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Functional status
timeFrame: 12 weeks
measure: Neuropathic pain mechanisms
timeFrame: 12 weeks
measure: Mental health
timeFrame: 12 weeks
measure: Central sensitization
timeFrame: 12 weeks
measure: Joint inflammation
timeFrame: 12 weeks
measure: Swollen joints
timeFrame: 12 weeks
measure: Inflammation-Erythrocyte sedimentation rate
timeFrame: 12 weeks
measure: Inflammation-CRP
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: David A Walsh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.