Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412484
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-01-22
Brief Title:
State vs Trait Alterations in Low Back Pain
Sponsor:
Schweinhardt Petra
Organization:
Balgrist University Hospital
Study Overview
Official Title:
Low Back Pain - Disentangling Trait-Like and State-Like Alterations
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain compared to healthy volunteers detected using several assessments psychophysical and neurophysiological testing imaging and blood sampling are dependent or independent of the presence and type of pain experienced at the time of investigation
Detailed Description:
The study consists of three visits healthy volunteers will only have one pain-free visit in which patients will be tested in a different pain state at each visit
1 Pain-free visit will be carried out when the patients have no or little Numerical Pain Rating Scale NPRS 210 clinical pain
2 Clinically relevant Low Back Pain visit will be carried out with patients experiencing a low back pain episode with an intensity of 310 or more on the NPRS
3 Experimental pain Clinically irrelevant pain visit will be carried out with the application of a high concentration 8 Qutenza capsaicin patch at the arm
Each of the visits will consist of psychophysical testing neurophysiological assessement of sweat activity in response to pain brain resting state magnetic resonance imaging and magnetic resonance spectroscopy Additionally and depending on the type of session a lumbar spine magnetic resonance image only pain-free session as characterization and a blood sample only pain free and low back pain visit will be performed
1 Pain-free visit will be carried out when the patients have no or little Numerical Pain Rating Scale NPRS 210 clinical pain
2 Clinically relevant Low Back Pain visit will be carried out with patients experiencing a low back pain episode with an intensity of 310 or more on the NPRS
3 Experimental pain Clinically irrelevant pain visit will be carried out with the application of a high concentration 8 Qutenza capsaicin patch at the arm
Each of the visits will consist of psychophysical testing neurophysiological assessement of sweat activity in response to pain brain resting state magnetic resonance imaging and magnetic resonance spectroscopy Additionally and depending on the type of session a lumbar spine magnetic resonance image only pain-free session as characterization and a blood sample only pain free and low back pain visit will be performed
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