Chronic Low-back Pain (cLBP)PAIN-MAPNCT07846163
Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling
An observational study of Chronic Low-back Pain (cLBP), run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This observational case-control study aims to investigate the central neurophysiological mechanisms underlying non-specific chronic low back pain (CLBP) with neural mechanosensitivity, with wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 7 Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients and healthy controls will be recruited through referrals from private physical therapy clinics and medical centers in Thessaloniki, as well as through an open call for expressions of interest to the broader community for voluntary participation.
Who may be able to join
- 18-45 years old
- Healthy/ free of pain
Who cannot join
- History of spinal injury
- History of cancer
- Bone metabolic diseases
- Inflammatory conditions (spondyloarthritis or systemic inflammatory diseases)
- Spondylolistethis
- Presence of neurological deficits suggesting active nerve root compression/radiculopathy (pathological of tendon reflexes, sensitivity and muscle strength)
Show all 11Show fewer
- Diagnosed neurodegenerative/neurological disorders or epilepsy
- Psychiatric disorders
- High irritability, according to Severity, Irritability, Nature, Stage, and Stability- SINSS pain assessment tool.
- Claustrophobia due to the measurement process inside the shielded room
- Electrical/electronic implants(e.g. pacemakers), metallic surgical materials (e.g. plates, stent) and dental and orthodontic metallic materials (e.g. braces).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Panagiotis D Bamidis, PhD contact
Greece1 site, 1 recruiting
- Recruiting
Laboratory of Medical Physics and Digital Innovation, AUTH
Thessaloniki, Central Macedonia, 54124
About this study
Official title: Exploring Pain: An OPM-MEG, Biomechanical, and Biopsychosocial Analysis in Chronic Low Back Pain
This observational case-control study aims to investigate the central neurophysiological mechanisms underlying non-specific chronic low back pain (CLBP) with neural mechanosensitivity, with wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG). The study evaluates brain activity dynamics at rest and during controlled movement-evoked pain. Additionally, it explores the relationship between cortical processing markers and multidimensional biopsychosocial profiles (including pain intensity, kinesiophobia, catastrophizing, sleep quality, and functional disability) and gait adaptaions in adults with CLBP aged 18 to 45 compared to healthy pain-free controls.
Read the detailed description
Chronic low back pain (CLBP) is a leading healthcare challenge, with a significant proportion of cases classified as non-specific (NSLBP). A distinct subset of CLBP patients presents with neural mechanosensitivity, often clinically confirmed via neurodynamic tests such as the Slump test. While traditional neuroimaging has advanced our understanding of pain processing, conventional methods like EEG lack spatial resolution for deep brain structures, and traditional SQUID-MEG systems severely restrict patient movement.
This study leverages the novel technology of wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG), allowing for non-invasive, high-resolution recording of brain activity during movement.
The study protocol involves screening for eligibility, comprehensive demographic and medical history collection, and a physical/neurological examination (including reflex, sensory, and muscle strength testing, alongside Straight Leg Raise and Slump tests). Participants complete validated psychometric questionnaires evaluating pain intensity, kinesiophobia, pain catastrophizing , sleep quality, functional disability, and quality of life. Furthermore, participants undergo a standardized 6-minute walk test using smart digital insoles to record spatiotemporal parameters, kinematic variables, and composite gait biomarkers.
Participants, also, perform a controlled, movement-evoked pain task (modified Slump-based knee extension/flexion protocol) designed to elicit mild, transient symptoms and a resting state recording.
The primary objectives are to map and compare resting-state and movement-evoked cortical oscillations, current density, and functional connectivity between CLBP patients and healthy controls, and to assess the predictive value of neurophysiological markers on psychological burden. Secondary objectives include identifying distinct pain phenotypes by integrating biomechanical, psychophysiological, and neural data.
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- OPM-MEG, Optically Pumped Magnetometers, Magnetoencephalography, Chronic Low Back Pain, Pain, Neural Mechanosensitivity, Biomechanics, Gait Analysis, SLUMP test, Kinesiophobia, Catastrophizing
- Medical subject headings
- Pain, Kinesiophobia
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 |
|---|---|---|
| CLBP | Adults aged 18-45 with chronic low back pain (>3 months) and neural mechanosensitivity. | |
| HC | Healthy volunteers without pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power spectral density as measured via OPM-MEG
Differences in oscillatory activity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the spectral power.
Measured: Baseline
Current density strength of the cortical activity as measured via OPM-MEG
Differences in cortical activity strength between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via an inverse solution algorithm.
Measured: Baseline
Cortical connectivity as measured via OPM-MEG
Differences in cortical connectivity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a connectivity metric estimated from the cortical activity, as reconstructed via an inverse solution algorithm.
Measured: Baseline
Network Topology as measured via OPM-MEG
Differences in network topology between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a graph measure estimated from the connectivity matrices of Outcome 3.
Measured: Baseline
Secondary outcomes (14)
Numerical Rating Pain Scale (NRPS)
Differences in pain intensity between groups and subgroups. This scale assesses subjective pain Intensity by selecting an integer from 0 to 10, where 0 represents complete absence of pain and 10 worst possible pain.
Measured: Baseline
Tampa Scale of Kinesiophobia (TSK)
Differences in kinesiophobia between groups and subgroups. This questionnaire assesses kinesiophobia, i.e. the patient's fear of movement, physical activity, or re-inury due to pain. It includes 17 statements, where each statement is rated on a 4-point Likert scale, from 1 "Strongly disagree" to 4 "Strongly agree". Certain items, such as 4,8,12 and 16 are reversed scored. The total score is derived from the sum of all answers, with higher values indicating greater fear of movement.
Measured: Baseline
Pain Catastrophizing Scale (PCS)
Differences in catastrophizing between groups and subgroups. This questionnaire measures pain catastrophizing i.e. the negative thoughts and excessive emotions experienced by the patient when in pain. It includes 13 statements. The patient rates each statement from 0 "Not at all" to 4 "All the time". The total score ranges from 0 to 52, with higher scores indicating higher levels of catastrophizing.
Measured: Baseline
Athens Insomnia Scale (AIS)
Differences in sleep quality and the likelihood of insomnia between groups and subgroups. This scale assesses sleep quality and the likelihood of insomnia. It consists of 8 questions and each question has 4 response option from 0 "no problem/adequate" to 3 "severe problem/very inadequate". Total scores range from 0 to 24, with higher scores indicating more severe insomnia problems.
Measured: Baseline
Functional Disability measured via Modified Oswestry Disability Index (ODI)
Differences in level of functional disability between groups and subgroups. This questionnaire measures the level of functional disability and how lower back pain affects daily activities. It consists of 10 questions. Each includes 6 possible answers scored from 0 (least impact) to 5 (maximum impact). The final score is calculated as a percentage ( total score of answers/ Maximum possible score x 100), where 0% means no disability and 100% maximum possible disability.
Measured: Baseline
Quality of life measured via World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Differences in quality of life between groups and subgroups. This questionnaire assess quality of life across four domains (physical health, psychological well-being, social relationships and environment) via 26 questions on a 1-5 scale. Each domain yields a score transformed into a 0-100 scale, where higher values reflect better quality.
Measured: Baseline
Distance walked during the 6-Minutes Walking Test (6-MWT)
Differences in distance walked during the 6-Minutes Walking Test between groups and subgroups. During the 6-Minutes Walking Test the total distance a person can walk on a flat, hard surface will be measured in meters (m).
Measured: Baseline
Average Walking Speed (km/h)
Differences in average walking speed between groups and subgroups. Average walking speed (kilometers per hour) will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Cadence (step/min)
Differences in cadence between groups and subgroups. Cadence will be calculated by the number of steps taken per minute (combined total of the two feet) and it will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Stride Length (cm)
Differences in stride length between groups and subgroups. Stride length will be calculated by the distance between two successive heel landings of the same foot and it will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Stance Time (ms and %)
Differences in stance time between groups and subgroups. Stance time will be calculated by the time during which the foot is in contact with the ground, standardized to be expressed as a percentage of the cycle time. It will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Swing Time (ms and %)
Differences in swing time between groups and subgroups. Swing time will be calculated by the time during which the foot is not in contact with the ground, standardized to be expressed as a percentage of the cycle time. It will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Double Support Time (%).
Differences in double support time between groups and subgroups. Double support time will be calculated by the percentage of the cycle during which both feet are in contact with the ground at the same time. It will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Symmetry Percentages (%) between the lower limbs
Differences in symmetry percentages between groups and subgroups. Symmetry expresses the congruence between the values obtained on the left and right foot for stance and swing time and determines whether one leg is used more than the other when walking. It will be measured during the 6-Minutes Walking Test.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start7 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panos Bamidis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846163
- Sponsor's protocol ID
- 684546
- Acronym
- PAIN-MAP
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding IPD sharing has not yet been finalized. Potential sharing of de-identified participant data will be evaluated in accordance with participant consent, GDPR requirements, ethical approvals, and institutional data-governance policies.
Publications
Zebhauser PT, Hohn VD, Ploner M. Resting-state electroencephalography and magnetoencephalography as biomarkers of chronic pain: a systematic review. Pain. 2023 Jun 1;164(6):1200-1221. doi: 10.1097/j.pain.0000000000002825. Epub 2022 Nov 28.
PubMed 36409624Wang WE, Ho RLM, Gatto B, van der Veen SM, Underation MK, Thomas JS, Antony AB, Coombes SA. Cortical dynamics of movement-evoked pain in chronic low back pain. J Physiol. 2021 Jan;599(1):289-305. doi: 10.1113/JP280735. Epub 2020 Nov 2.
PubMed 33067807Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Pain: An OPM-MEG, Biomechanical, and Biopsychosocial Analysis in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07846163
- Acronym / sponsor ID
- PAIN-MAP / 684546
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- OPM-MEG, Optically Pumped Magnetometers, Magnetoencephalography, Chronic Low Back Pain, Pain, Neural Mechanosensitivity, Biomechanics, Gait Analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Sep 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.
This observational case-control study aims to investigate the central neurophysiological mechanisms underlying non-specific chronic low back pain (CLBP) with neural mechanosensitivity, with wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG). The study evaluates brain activity dynamics at rest and during controlled movement-evoked pain. Additionally, it explores the relationship between cortical processing markers and multidimensional biopsychosocial profiles (including pain intensity, kinesiophobia, catastrophizing, sleep quality, and functional disability) and gait adaptaions in adults with CLBP aged 18 to 45 compared to healthy pain-free controls.
Detailed description
Chronic low back pain (CLBP) is a leading healthcare challenge, with a significant proportion of cases classified as non-specific (NSLBP). A distinct subset of CLBP patients presents with neural mechanosensitivity, often clinically confirmed via neurodynamic tests such as the Slump test. While traditional neuroimaging has advanced our understanding of pain processing, conventional methods like EEG lack spatial resolution for deep brain structures, and traditional SQUID-MEG systems severely restrict patient movement.
This study leverages the novel technology of wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG), allowing for non-invasive, high-resolution recording of brain activity during movement.
The study protocol involves screening for eligibility, comprehensive demographic and medical history collection, and a physical/neurological examination (including reflex, sensory, and muscle strength testing, alongside Straight Leg Raise and Slump tests). Participants complete validated psychometric questionnaires evaluating pain intensity, kinesiophobia, pain catastrophizing , sleep quality, functional disability, and quality of life. Furthermore, participants undergo a standardized 6-minute walk test using smart digital insoles to record spatiotemporal parameters, kinematic variables, and composite gait biomarkers.
Participants, also, perform a controlled, movement-evoked pain task (modified Slump-based knee extension/flexion protocol) designed to elicit mild, transient symptoms and a resting state recording.
The primary objectives are to map and compare resting-state and movement-evoked cortical oscillations, current density, and functional connectivity between CLBP patients and healthy controls, and to assess the predictive value of neurophysiological markers on psychological burden. Secondary objectives include identifying distinct pain phenotypes by integrating biomechanical, psychophysiological, and neural data.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLBP | – | –Adults aged 18-45 with chronic low back pain (>3 months) and neural mechanosensitivity. |
| HC | – | –Healthy volunteers without pain. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients and healthy controls will be recruited through referrals from private physical therapy clinics and medical centers in Thessaloniki, as well as through an open call for expressions of interest to the broader community for voluntary participation.
Key inclusion criteria (2 listed)
- 18-45 years old
- Healthy/ free of pain
Key exclusion criteria (11 listed)
- History of spinal injury
- History of cancer
- Bone metabolic diseases
- Inflammatory conditions (spondyloarthritis or systemic inflammatory diseases)
- Spondylolistethis
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
Power spectral density as measured via OPM-MEG
Time frame: Baseline
Differences in oscillatory activity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the spectral power.
Current density strength of the cortical activity as measured via OPM-MEG
Time frame: Baseline
Differences in cortical activity strength between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via an inverse solution algorithm.
Cortical connectivity as measured via OPM-MEG
Time frame: Baseline
Differences in cortical connectivity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a connectivity metric estimated from the cortical activity, as reconstructed via an inverse solution algorithm.
Network Topology as measured via OPM-MEG
Time frame: Baseline
Differences in network topology between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of a graph measure estimated from the connectivity matrices of Outcome 3.
14 secondary outcomes
Numerical Rating Pain Scale (NRPS)
Time frame: Baseline
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline
Pain Catastrophizing Scale (PCS)
Time frame: Baseline
Athens Insomnia Scale (AIS)
Time frame: Baseline
Functional Disability measured via Modified Oswestry Disability Index (ODI)
Time frame: Baseline
Quality of life measured via World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Baseline
Distance walked during the 6-Minutes Walking Test (6-MWT)
Time frame: Baseline
Average Walking Speed (km/h)
Time frame: Baseline
Cadence (step/min)
Time frame: Baseline
Stride Length (cm)
Time frame: Baseline
Stance Time (ms and %)
Time frame: Baseline
Swing Time (ms and %)
Time frame: Baseline
Double Support Time (%).
Time frame: Baseline
Symmetry Percentages (%) between the lower limbs
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 36409624Zebhauser PT, Hohn VD, Ploner M. Resting-state electroencephalography and magnetoencephalography as biomarkers of chronic pain: a systematic review. Pain. 2023 Jun 1;164(6):1200-1221. doi: 10.1097/j.pain.0000000000002825. Epub 2022 Nov 28.
- Background: PubMed 33067807Wang WE, Ho RLM, Gatto B, van der Veen SM, Underation MK, Thomas JS, Antony AB, Coombes SA. Cortical dynamics of movement-evoked pain in chronic low back pain. J Physiol. 2021 Jan;599(1):289-305. doi: 10.1113/JP280735. Epub 2020 Nov 2.
- Background: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
- Individual participant dataSharing planned: Undecided. The decision regarding IPD sharing has not yet been finalized. Potential sharing of de-identified participant data will be evaluated in accordance with participant consent, GDPR requirements, ethical approvals, and institutional data-governance policies.
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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.
Panagiotis D Bamidis, PhD contact
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 Chronic Low-back Pain (cLBP), run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 Sep 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia M Keklikoglou, MSc Student (2310999310, nkeklik@ece.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power spectral density as measured via OPM-MEG (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07846163, which also lists 3 linked publications.
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 29 Sep 2026.