Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574165
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAN
Brief Summary:
Fibromyalgia FM is a chronic pain condition that disproportionately impacts Veterans Individuals diagnosed with FM patients experience lower self-esteem and positive affect as well as greater levels of depression anxiety negative affect and pain catastrophizing Among those experiencing FM clinical and experimental pain are associated with specific dispositional trait profiles which are indexed by levels of negative affect and positive affect Neuroinflammation and inflammation also play a role in FM- related affect and pain Recent studies that have highlighted neuroinflammation and inflammation as physiological mechanisms associated with changes in dysregulated affect and chronic pain Veterans with FM can ameliorate their dispositional traits-ie increasing positive affect and reducing negative affect-by participating in exercise However a gap exists regarding how to optimally engage Veterans with FM in an exercise program Thus to fully take advantage of all potential therapeutic benefits of exercise for FM there is a critical need to identify those factors underlying exercise engagement for FM pain management The purpose for this study is to 1 determine associations of dispositional trait styles neuroinflammation and inflammation with pain outcomes in Veterans with FM and 2 develop and design a Veteran-informed exercise program
Detailed Description:
The investigators propose to recruit 20 Veterans with FM and 20 Veterans without FM who will undergo magnetic resonance spectroscopy imaging MRSI scans pain assessments and semi-structured interviews They will undergo a 6-week moderate intensity continuous training exercise intervention and follow-up MRSI scans pain assessments and semi-structured interviews The investigators central hypothesis is that dispositional trait styles neuroinflammation and inflammation will be associated with pain outcomes and exercise will induce beneficial anti-inflammatory changes The research objective of this proposal is two-fold 1 to acquire data on the associations between dispositional trait styles neuroinflammation inflammation and pain in Veterans with FM and 2 to develop a Veteran-informed exercise program with potential to modify dispositional trait styles neuroinflammation inflammation and pain in Veterans with FM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None