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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515589
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 12, 2021
Sponsor:
Collaborators:
Versus Arthritis
Pfizer
Information provided by (Responsible Party):
University of Nottingham

Study Description
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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).

Condition or disease
Rheumatoid Arthritis

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 Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Aspects of Pain in Rheumatoid Arthritis
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Main study cohort
The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. Bodily pain [ Time Frame: 12 weeks ]
    Numerical Rating Scale (0-10) of bodily pain - increasing severity


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Fatigue [ Time Frame: 12 weeks ]
    Bristol Rheumatoid Arthritis Multidimensional Fatigue Scale (BRAFS). 0-70 scale of increasing fatigue.

  4. Change and trajectory of bodily pain [ Time Frame: 12 weeks ]
    Responses to mobile phone text messages giving 0-10 pain scores.

  5. Change and trajectory of fatigue [ Time Frame: 12 weeks ]
    Responses to mobile phone text messages giving 0-10 fatigue scores

  6. Physical activity [ Time Frame: 12 weeks ]
    International Physical Activity Questionnaire (IPAQ) -short form. Lower scores indicate less physical activity.

  7. Functional status [ Time Frame: 12 weeks ]
    Health Assessment Questionnaire (HAQ). Range 0-3 with higher scores indicating greater disability.

  8. Neuropathic pain mechanisms [ Time Frame: 12 weeks ]
    PainDETECT. Higher scores indicating greater neuropathic pain mechanisms.

  9. 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.

  10. Central sensitization [ Time Frame: 12 weeks ]
    Central Sensitisation Inventory 9 (CSI-9). Higher scores indicate greater central sensitisation.

  11. Joint inflammation [ Time Frame: 12 weeks ]
    Ultrasound assessment showing synovitis

  12. Swollen joints [ Time Frame: 12 weeks ]
    Swollen joint count (0-28)

  13. Inflammation-Erythrocyte sedimentation rate [ Time Frame: 12 weeks ]
    Erythrocyte sedimentation rate (mm per hour)

  14. Inflammation-CRP [ Time Frame: 12 weeks ]
    High sensitivity C-reactive protein


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515589


Contacts
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Contact: Onosi S Ifesemen +441153231810 mbxosi@nottingham.ac.uk
Contact: Daniel F McWilliams +441153231942 dan.mcwilliams@nottingham.ac.uk

Locations
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United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, United Kingdom
Contact: Alison Steel         
Principal Investigator: David A Walsh, FRCP PhD         
Sponsors and Collaborators
University of Nottingham
Versus Arthritis
Pfizer
Investigators
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Principal Investigator: David A Walsh University of Nottingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04515589    
Other Study ID Numbers: 20001
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: April 2021
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Pain
Fatigue
Central Sensitization
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases