Central Aspects of Pain in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— CAP-RA  

Official title:

Central Aspects of Pain in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515589
• Other study ID #: 20001
• Status: Completed
• Start date: August 11, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United Kingdom	Sherwood Forest Hospitals NHS Foundation Trust	Mansfield	Nottinghamshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Pfizer, Versus Arthritis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric properties of CAP-RA	A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain.	Baseline
Primary	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
Primary	Bodily pain	Numerical Rating Scale (0-10) of bodily pain - increasing severity	12 weeks
Secondary	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
Secondary	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
Secondary	Fatigue	Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue.	12 weeks
Secondary	Change and trajectory of bodily pain	Responses to mobile phone text messages giving 0-10 pain scores.	12 weeks
Secondary	Change and trajectory of fatigue	Responses to mobile phone text messages giving 0-10 fatigue scores	12 weeks
Secondary	Physical activity	International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity.	12 weeks
Secondary	Functional status	Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability.	12 weeks
Secondary	Neuropathic pain mechanisms	PainDETECT. Higher scores indicating greater neuropathic pain mechanisms.	12 weeks
Secondary	Mental health	Hospital Anxiety and Depression Scale (HADS) - depression and anxiety. Higher scores indicating worse feelings of anxiety and lower mood.	12 weeks
Secondary	Central sensitization	Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation.	12 weeks
Secondary	Joint inflammation	Ultrasound assessment showing synovitis	12 weeks
Secondary	Swollen joints	Swollen joint count (0-28)	12 weeks
Secondary	Inflammation-Erythrocyte sedimentation rate	Erythrocyte sedimentation rate (mm per hour)	12 weeks
Secondary	Inflammation-CRP	High sensitivity C-reactive protein	12 weeks