- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07846163
Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling (PAIN-MAP)
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Panagiotis D Bamidis, PhD
연구 연락처 백업
- 이름: Natalia M Keklikoglou, MSc Student
- 전화번호: 2310999310
- 이메일: nkeklik@ece.auth.gr
연구 장소
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Central Macedonia
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Thessaloniki, Central Macedonia, 그리스, 54124
- 모병
- Laboratory of Medical Physics and Digital Innovation, AUTH
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
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CLBP
Adults aged 18-45 with chronic low back pain (>3 months) and neural mechanosensitivity. |
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HC
Healthy volunteers without pain. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Power spectral density as measured via OPM-MEG
기간: Baseline
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Differences in oscillatory activity between groups and subgroups. Difference is defined as statistical significance in the t-test comparison of the spectral power. |
Baseline
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Current density strength of the cortical activity as measured via OPM-MEG
기간: Baseline
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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
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Cortical connectivity as measured via OPM-MEG
기간: Baseline
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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
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Network Topology as measured via OPM-MEG
기간: Baseline
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numerical Rating Pain Scale (NRPS)
기간: 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
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Tampa Scale of Kinesiophobia (TSK)
기간: Baseline
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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
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Pain Catastrophizing Scale (PCS)
기간: Baseline
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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
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Athens Insomnia Scale (AIS)
기간: Baseline
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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
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Functional Disability measured via Modified Oswestry Disability Index (ODI)
기간: Baseline
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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
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Quality of life measured via World Health Organization Quality of Life-BREF (WHOQOL-BREF)
기간: 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
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Distance walked during the 6-Minutes Walking Test (6-MWT)
기간: Baseline
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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
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Average Walking Speed (km/h)
기간: 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
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Cadence (step/min)
기간: Baseline
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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
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Stride Length (cm)
기간: Baseline
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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
|
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Stance Time (ms and %)
기간: Baseline
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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
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Swing Time (ms and %)
기간: Baseline
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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
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Double Support Time (%).
기간: Baseline
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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
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Symmetry Percentages (%) between the lower limbs
기간: Baseline
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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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Hartvigsen 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.
- 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.
- Wang 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 684546
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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