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State vs. Trait Alterations in Low Back Pain

NCT06412484 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-05-14

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • Schweinhardt Petra

    lead OTHER

Principal Investigators

  • Petra Schweinhardt · University of Zurich

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06412484 on ClinicalTrials.gov