Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA)

• ClinicalTrials.gov Identifier: NCT04515589
• Recruitment Status: Not yet recruiting
• First Posted: August 17, 2020
• Last Update Posted: November 4, 2020
• Sponsor: University of Nottingham
• Collaborators: Versus Arthritis; Pfizer
• Information provided by (Responsible Party): University of Nottingham

Tracking Information

• First Submitted Date: August 6, 2020
• First Posted Date: August 17, 2020
• Last Update Posted Date: November 4, 2020
• Estimated Study Start Date: December 1, 2020
• Estimated Primary Completion Date: July 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 14, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Central Aspects of Pain in Rheumatoid Arthritis
• Official Title: Central Aspects of Pain in Rheumatoid Arthritis
• 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 SMS for 12 weeks.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood samples

• 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.
• Condition: Rheumatoid Arthritis
• Intervention: Not Provided

Study Groups/Cohorts

Main study cohort

The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 14, 2020): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2022
• Estimated Primary Completion Date: July 30, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Onosi S Ifesemen; +441153231810; mbxosi@nottingham.ac.uk

Contact: Daniel F McWilliams; +441153231942; dan.mcwilliams@nottingham.ac.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04515589
• Other Study ID Numbers: 20001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: 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.

• Responsible Party: University of Nottingham
• Study Sponsor: University of Nottingham

Collaborators

• Versus Arthritis
• Pfizer

Investigators

• Principal Investigator: David A Walsh; University of Nottingham

• PRS Account: University of Nottingham
• Verification Date: November 2020