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

22 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

60

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Panagiotis D Bamidis, PhD

Kopia zapasowa kontaktu do badania

  • Nazwa: Natalia M Keklikoglou, MSc Student
  • Numer telefonu: 2310999310
  • E-mail: nkeklik@ece.auth.gr

Lokalizacje studiów

  • Grecja
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Grecja, 54124
        • Rekrutacyjny
        • Laboratory of Medical Physics and Digital Innovation, AUTH

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: CASE_CONTROL
  • Perspektywy czasowe: CROSS_SECTIONAL

Kohorty i interwencje

Grupa / Kohorta
CLBP

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

Healthy volunteers without pain.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Power spectral density as measured via OPM-MEG
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Numerical Rating Pain Scale (NRPS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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 %)
Ramy czasowe: 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 %)
Ramy czasowe: 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 (%).
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Aristotle University Of Thessaloniki

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

16 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 września 2026

Pierwszy wysłany (Rzeczywisty)

29 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 684546

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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