Nonspecific Chronic Low Back PainNCT07896785
Body and the Brain: Cortical Reactivity and Cognitive-Affective Regulation to Experimental Pain.
An observational study of Nonspecific Chronic Low Back Pain, run by Oregon Health and Science University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonspecific Chronic Low Back Pain
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97229
About this study
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.
- Conditions
- Nonspecific Chronic Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at time of subject enrollment
Secondary outcomes (4)
Pain-Related Evoked Potentials (Habituation)
Pain habitation is measured by change of PREP amplitudes between the first and third block of electrical stimulation.
Measured: at time of subject enrollment
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.
Measured: At time of subject enrollment
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.
Measured: At time of subject enrollment
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.
Measured: At time of subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Apr 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry D Oken, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896785
- Sponsor's protocol ID
- STUDY00018625
- Other IDs
- T32AT002688, K24AT005121
- Status last verified
- Jun 2022
- First submitted
- 26 Apr 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body and the Brain: Cortical Reactivity and Cognitive-Affective Regulation to Experimental Pain.
- ClinicalTrials.gov ID
- NCT07896785
- Acronym / sponsor ID
- STUDY00018625
- Conditions
- Nonspecific Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain-Related Evoked Potentials (amplitude)
Time frame: at time of subject enrollment
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).
4 secondary outcomes
Pain-Related Evoked Potentials (Habituation)
Time frame: at time of subject enrollment
Pain Catastrophizing Scale
Time frame: At time of subject enrollment
Five Facets of Mindfulness Questionnaire
Time frame: At time of subject enrollment
Multidimensional Assessment of Interoceptive Awareness
Time frame: At time of subject enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry D Oken, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonspecific Chronic Low Back Pain, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-Related Evoked Potentials (amplitude) (time frame: at time of subject enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.