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CompletedNCT07896785Updated Oct 27, 2026

Body and the Brain: Cortical Reactivity and Cognitive-Affective Regulation to Experimental Pain.

An observational study in Nonspecific Chronic Low Back Pain, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Oregon Health and Science University · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
26
Ages
30 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 711 studies in Low Back Pain with a site in United States — 99 open to participants now, 125 under way, 3 of them phase 3. Low Back Pain · United States.

Enrollment
67th of 84
26 · median 89
Started
2019
with 44 others
Observational
86 of 711
18 open now
Registered
459th of 711
by date

Among the 711 studies in Low Back Pain with a site in United States, this one is the 67th largest by enrollment of the 84 observational ones, is one of 45 that started in 2019, is one of 86 observational ones, and was the 459th registered.

By phase

711 studies; the count open now beside each. This study's row is marked.

No phase408 · 62 open
Observationalthis study86 · 18 open
Phase 362 · 1 open
Phase 259 · 7 open
Phase 450 · 4 open
Phase 125 · 5 open
Phase 2/311 · 1 open
Phase 1/210 · 1 open

By the year they started

First in 1977; this study’s year is marked. 45 started in 2019.

Size and results

Median enrollment 78 across the 623 interventional studies, 89 across the 84 observational. Of the 512 that completed or were terminated, 206 (40%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 711 studies in Low Back Pain with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

Aim 1:To compare amplitudes of pain-related evoked potentials during electrical paired-pulse stimulation between individuals with non-specific chronic low back pain and healthy controls.

Aim 2: To compare differences in pain habituation between individuals with non-specific chronic low back pain and healthy controls.

Aim 3: To compare cognitive-affective regulation between individuals with non-specific chronic low back pain and healthy controls.

03

Conditions studied

  • Nonspecific Chronic Low Back Pain

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04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 30-70 years old.
  • Agrees to follow the study protocol.
  • Reports a stable regimen of pharmacologic and/or non-pharmacologic treatments, meaning they have not changed their medication in the last 2 months.
  • Access to an internet for REDCap survey.

Exclusion criteria

Exclusion Criteria:

  • Significant patient-reported medical/neurological disease (e.g., major organ failure; active cancer, stroke, migraine, multiple sclerosis, Parkinson disease, Alzheimer disease, epilepsy)
  • Peripheral, entrapment, or radiculopathy neuropathies of the upper extremities (associated with diabetes, chemotherapy, or drug use, or imaging finding of a herniated disk or foraminal stenosis in the neck with contact to a nerve root); history of ulnar neuropathy or median nerve neuropathy
  • Acute and/or symptomatic compression fracture confirmed by imaging
  • Previous spinal surgery
  • Rheumatoid arthritis
  • Use of analgesic medication the morning prior to the afternoon assessment.
  • Cannot understand the instructions (e.g., cannot hear or see study materials).
  • Involved in a workers' compensation case, currently undergoing disability application, involved in personal injury claim, or incarcerated.
  • Pregnant or seeking to become pregnant.
  • Presence of an implantable electronic device such as a cardiac pacemaker, ICD, DBS, vagus nerve stimulator.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy Controls

    Healthy individuals ages 30-70 years old.

  • Nonspecific Chronic Low Back Pain

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: at time of subject enrollment

Secondary outcomes

  1. Pain-Related Evoked Potentials (Habituation)

    Pain habitation is measured by change of PREP amplitudes between the first and third block of electrical stimulation.

    Time frame: at time of subject enrollment

  2. Pain Catastrophizing Scale

    A psychological assessment tool designed to measure the extent of catastrophic thinking related to pain. It evaluates how individuals perceive and react to pain, focusing on their thoughts and feelings during painful experiences.

    Time frame: At time of subject enrollment

  3. Five Facets of Mindfulness Questionnaire

    Widely used tool designed to assess an individual's level of mindfulness across five distinct dimensions: Observing: Noticing or attending to internal and external experiences, such as thoughts, feelings, and sensations. Describing: The ability to put feelings and experiences into words. Acting with Awareness: Engaging in activities with full attention rather than on autopilot. Non-judging of Inner Experience: Accepting thoughts and feelings without criticism or evaluation. Non-reactivity to Inner Experience: Allowing thoughts and feelings to come and go without getting caught up in them.

    Time frame: At time of subject enrollment

  4. Multidimensional Assessment of Interoceptive Awareness

    An adult self-report measure that assesses interoceptive awareness, or how individuals perceive, interpret, and respond to internal bodily sensations.

    Time frame: At time of subject enrollment

07

Study locations

1 site
  • Oregon Health and Science University
    Portland, Oregon 97229, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 3 months after publication and up to five years following publication.

Access criteria: To individuals who provide a methodologically sound proposal for any purpose.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Apr 2022, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2019
First posted
Oct 27, 2026
StartActual
Apr 1, 2019
Primary completionActual
Apr 1, 2022
CompletionActual
Apr 1, 2022
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896785
Responsible party
Barry S. Oken (Professor, Oregon Health and Science University) — Principal investigator
First posted
Oct 27, 2026
Start date
Apr 1, 2019
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022
Last update
Oct 27, 2026

Study contacts

Barry D Oken, MD, PhD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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