NCT04515589

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

August 11, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

August 6, 2020

Last Update Submit

November 28, 2023

Conditions

Rheumatoid Arthritis

Keywords

PainFatigueCentral Sensitization

Outcome Measures

Primary Outcomes (3)

  • Psychometric properties of CAP-RA

    A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain.

    Baseline

  • 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

  • Bodily pain

    Numerical Rating Scale (0-10) of bodily pain - increasing severity

    12 weeks

Secondary Outcomes (14)

  • Quantitative Sensory Testing

    Baseline

  • Quantitative Sensory Testing

    12 weeks

  • Fatigue

    12 weeks

  • Change and trajectory of bodily pain

    12 weeks

  • Change and trajectory of fatigue

    12 weeks

  • +9 more secondary outcomes

Study Arms (1)

Main study cohort

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherwood Forest Hospitals NHS Foundation Trust

Mansfield, Nottinghamshire, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34162435DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Arthritis, RheumatoidPainFatigue

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David A Walsh

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 17, 2020

Study Start

August 11, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations

GB(1)