NCT06412484

State vs. Trait Alterations in Low Back Pain

Low Back Pain - Disentangling Trait-Like and State-Like Alterations

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Schweinhardt Petra · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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) \</= 2/10) 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 3/10 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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Pain Free Session	On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail): clinical exam, QST, SSRs, CPM, rsMRI, lumbar MRI, MRS, and blood sample.
BEHAVIORAL	Low Back Pain Session (= clinically relevant pain)	On a day in which patients have an ongoing typical low back pain episode of an intensity of 3 or more (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail), except the lumbar MRI: clinical exam, QST, SSRs, CPM, rsMRI, MRS, and blood sample.
BEHAVIORAL	Experimental Pain Session (= clinically irrelevant pain)	On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), an experimental pain state will be induced using a high concentration (8%) Qutenza patch, containing capsaicin. All the study measures will be performed (see primary outcome measures for detail), except the lumbar MRI and blood sample: clinical exam, QST, SSRs, CPM, rsMRI, MRS.

Timeline

• Start date: 2023-10-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-05-14
• Last updated: 2024-05-14

Locations

1 site across 1 country: Switzerland