Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04515589
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2020-08-06
Brief Title:
Central Aspects of Pain in Rheumatoid Arthritis
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Central Aspects of Pain in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP-RA
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None