Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
80 participants
OBSERVATIONAL
2023-10-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization
NCT04974229
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.
NCT04433299
Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.
NCT05097235
Prognostic Value of Measures of the Central Hypersensitivity in Patients With Acute Low Back Pain
NCT00892411
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
NCT00924495
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Back Pain (LBP) Patients
LBP patients will undergo three study visits, at moments at which their pain status is different: a) "pain-free", b) low back pain (clinically relevant), c) experimental pain (clinically irrelevant). Measures will be repeated in each visit, to understand the influence / relationship of pain state on possible mechanistic alterations observed in LBP compared to HCs.
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.
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.
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.
Healthy Controls (HCs)
HCs will undergo one single visit, equivalent to patients' "pain-free" visit.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent
* Low back pain for more than 3 months
* Low back pain clinically not attributable to "red flags" (e.g. infection, fractures, inflammation)
* Fluctuating course of pain (with on and off pain periods).
Exclusion Criteria
* Major medical or psychiatric condition. E.g. severe heart disease, diabetes, autoimmune disorders, rheumatic disorders, major depressive disorder, etc.
* Symptomatic radiculopathy, manifested through motor and/or sensory deficits / or signs of nerve root involvement on lumbar MRI.
* Back operation
* BMI \> 30
* Pregnancy
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Schweinhardt Petra
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Schweinhardt Petra
Prof. Dr. Med. PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Petra Schweinhardt
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Balgrist Campus
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRPP Renewal
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.