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Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling (PAIN-MAP)

22 september 2026 bijgewerkt door: Panos Bamidis, Aristotle University Of Thessaloniki

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

60

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Panagiotis D Bamidis, PhD

Studie Contact Back-up

  • Naam: Natalia M Keklikoglou, MSc Student
  • Telefoonnummer: 2310999310
  • E-mail: nkeklik@ece.auth.gr

Studie Locaties

  • Griekenland
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Griekenland, 54124
        • Werving
        • Laboratory of Medical Physics and Digital Innovation, AUTH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria (Group of Chronic Low Back Pain Patients):

  • 18-45 years old
  • Non-specific low back pain
  • Duration of pain > 3 months
  • Positive SLUMP test

Inclusion Criteria (Group of Healthy Control Participants):

  • 18-45 years old
  • Healthy/ free of pain

Exclusion Criteria (Common for both groups):

  • 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)
  • 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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: CASE_CONTROL
  • Tijdsperspectieven: CROSS_SECTIONAL

Cohorten en interventies

Groep / Cohort
CLBP

Adults aged 18-45 with chronic low back pain (>3 months) and neural mechanosensitivity.
HC

Healthy volunteers without pain.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Power spectral density as measured via OPM-MEG
Tijdsspanne: Baseline

Differences in oscillatory activity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the spectral power.
Baseline
Current density strength of the cortical activity as measured via OPM-MEG
Tijdsspanne: 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.
Baseline
Cortical connectivity as measured via OPM-MEG
Tijdsspanne: 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.
Baseline
Network Topology as measured via OPM-MEG
Tijdsspanne: 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.
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Numerical Rating Pain Scale (NRPS)
Tijdsspanne: Baseline

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.
Baseline
Tampa Scale of Kinesiophobia (TSK)
Tijdsspanne: Baseline

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.
Baseline
Pain Catastrophizing Scale (PCS)
Tijdsspanne: Baseline

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.
Baseline
Athens Insomnia Scale (AIS)
Tijdsspanne: Baseline

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.
Baseline
Functional Disability measured via Modified Oswestry Disability Index (ODI)
Tijdsspanne: Baseline

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.
Baseline
Quality of life measured via World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Tijdsspanne: Baseline

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.
Baseline
Distance walked during the 6-Minutes Walking Test (6-MWT)
Tijdsspanne: Baseline

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).
Baseline
Average Walking Speed (km/h)
Tijdsspanne: Baseline

Differences in average walking speed between groups and subgroups. Average walking speed (kilometers per hour) will be measured during the 6-Minutes Walking Test.
Baseline
Cadence (step/min)
Tijdsspanne: Baseline

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.
Baseline
Stride Length (cm)
Tijdsspanne: Baseline

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.
Baseline
Stance Time (ms and %)
Tijdsspanne: Baseline

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.
Baseline
Swing Time (ms and %)
Tijdsspanne: Baseline

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.
Baseline
Double Support Time (%).
Tijdsspanne: Baseline

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.
Baseline
Symmetry Percentages (%) between the lower limbs
Tijdsspanne: Baseline

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.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aristotle University Of Thessaloniki

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 september 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

16 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2026

Eerst geplaatst (Werkelijk)

29 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 684546

Plan Individuele Deelnemersgegevens (IPD)

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Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

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Nee

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Nee

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