Sponsor study identifier
Secondary identifiers
NIH
NIH
observational
26
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
April 1, 2022
Actual (reported)Study Completion
April 1, 2022
Actual (reported)The purpose of this cross-sectional study is to compare cortical reactivity and cognitive-affective regulation in response to experimental pain between healthy controls and individuals with non-specific chronic low back pain.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)April 26, 2019
Actual (reported)April 1, 2022
Actual (reported)April 1, 2022
Actual (reported)October 27, 2026
Actual (reported)Pain-Related Evoked Potentials (amplitude)
Cortical pain habituation is acquired via pain-related evoked potentials (PREPs): time-locked neural responses to painful electrical stimuli derived from an ongoing EEG. Electrical pulses are delivered using a constant current via a custom-built concentric electrode taped onto the radial side of the dorsum of the non-dominate hand. The electrode is connected to the electrical stimulator, Digitimer DS7A (Digitimer Ltd, Welwyn Garden City, Hertfordshire, UK), which provides standardized, precisely-delivered electrical stimuli. EEG is collected using a BioSemi 32-channel ActiveTwo system using active-sensor Ag-AgCl electrodes (BioSemi, Amsterdam).
at time of subject enrollment
Pain-Related Evoked Potentials (Habituation)
at time of subject enrollment
Pain Catastrophizing Scale
At time of subject enrollment
Five Facets of Mindfulness Questionnaire
At time of subject enrollment
Multidimensional Assessment of Interoceptive Awareness
At time of subject enrollment
Healthy individuals ages 30-70 years old.
Individuals ages 30-70 years old with nonspecific chronic low back pain for at least 3 months with pain on at least half the days during the last 6 months.
Non-specific chronic low back pain (cLBP). Human participants with non-specific cLBP will be studied. Nonspecific cLBP is a broadly used-term to suggest that patient-reported pain cannot be explained by known tissue damage, inflammatory responses, or neuropathy. Enrolled participants will have experienced pain that has persisted for longer than 3 months and for at least half of the days during the past 6 months. Further, pain will interfere with activities of daily life and participation in social roles.
Oregon Health and Science University
Portland, Oregon, 97229, United States
saliva cortisol
Barry D Oken, MD, PhD
Oregon Health and Science University
26 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2019
First Posted
October 27, 2026
Study Start
April 1, 2019
Actual (reported)V-sitting Posture Stabilization Versus Modified Clamshell in Patients With Non-specific Chronic Low Back Pain.
Contact the study team to confirm eligibility.
Primary Completion
April 1, 2022
Actual (reported)Study Completion
April 1, 2022
Actual (reported)Last Updated
October 27, 2026
Record last verified: 2022-06
Individual participant data that underlie the results reported in the article, after de-identification will be shared. Study protocols, statistical analyses plan, and the analytic code will be provided beginning 3 months after and ending 5 years following the article publication to individuals who provide a methodologically sound proposal for any purpose.Proposals should be directed to colgand@ohsu.edu. To gain access, requestors will need to sign a data access agreement.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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