Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-31 @ 6:01 PM
Study NCT ID:
NCT06669767
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Indicators of Pain Representation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092442', 'term': 'Kinesiophobia'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard deviation of the position of the center of pressure on the anteroposterior axis (SD-COP-AP)', 'timeFrame': 'Baseline', 'description': 'Movements of the center of pressure (COP) are recorded using a force plate, and the SD-COP-AP is calculated after recording and is an indicator of the postural response.'}], 'secondaryOutcomes': [{'measure': 'Mean position of the center of pressure on the anteroposterior axis (COP-AP)', 'timeFrame': 'Baseline'}, {'measure': 'Mean position of the center of pressure on the mediolateral axis (COP-ML)', 'timeFrame': 'Baseline'}, {'measure': 'Standard deviation of the position of the center of pressure on the mediolateral axis (SD-COP-ML)', 'timeFrame': 'Baseline'}, {'measure': 'Sway length of the center of pressure on the anteroposterior axis (L-COP-AP)', 'timeFrame': 'Baseline'}, {'measure': 'Sway length of the center of pressure on the mediolateral axis (L-COP-ML)', 'timeFrame': 'Baseline'}, {'measure': 'Tibialis anterior muscle activity', 'timeFrame': 'Baseline', 'description': 'Measured by electromyography, RMS normalized to maximum voluntary contraction.'}, {'measure': 'Soleus muscle activity', 'timeFrame': 'Baseline', 'description': 'Measured by electromyography, RMS normalized to maximum voluntary contraction.'}, {'measure': 'Longissimus dorsi muscle activity', 'timeFrame': 'Baseline', 'description': 'Measured by electromyography, RMS normalized to maximum voluntary contraction.'}, {'measure': 'Co-activation (Soleus/Tibialis anterior)', 'timeFrame': 'Baseline'}, {'measure': 'Coefficient of variation for muscle activity of tibialis anterior', 'timeFrame': 'Baseline'}, {'measure': 'Coefficient of variation for muscle activity of soleus', 'timeFrame': 'Baseline'}, {'measure': 'Coefficient of variation for muscle activity of longissimus dorsi', 'timeFrame': 'Baseline'}, {'measure': 'Mean heart rate', 'timeFrame': 'Baseline'}, {'measure': 'Mean RR interval', 'timeFrame': 'Baseline'}, {'measure': 'Standard deviation of normal RR intervals (SDNN)', 'timeFrame': 'Baseline'}, {'measure': 'Root mean square of successive R-R intervals (RMSSD)', 'timeFrame': 'Baseline'}, {'measure': 'Power of very low frequency from frequency analysis (VLF)', 'timeFrame': 'Baseline'}, {'measure': 'Power of low frequency from frequency analysis (LF)', 'timeFrame': 'Baseline'}, {'measure': 'Power of high frequency from frequency analysis (HF)', 'timeFrame': 'Baseline'}, {'measure': 'Ratio of LF/HF (post-frequency analysis)', 'timeFrame': 'Baseline'}, {'measure': 'Tampa scale for kinesiophobia (TSK) score', 'timeFrame': 'Baseline', 'description': 'Kinesiophobia was evaluated with the Tampa Scale for Kinesiophobia (TSK), a self-administered questionnaire validated in French. The TSK measures the fear of movement and is used in various painful conditions. It includes 17 items evaluated on a 4-point Likert scale. The total score range is 17-68 and a high score indicates a greater fear of movement.'}, {'measure': 'Brief pain inventory (BPI) score', 'timeFrame': 'Baseline', 'description': 'Pain was assessed with the Brief Pain Inventory (BPI), a reliable self-administered questionnaire about pain severity (4 items) and interference with daily living (7 items) validated in French. Each item is evaluated on a numerical scale from 0 to 10. A high score indicates significant pain or significant interference in daily living.'}, {'measure': 'EQ-5D-5L questionnaire score', 'timeFrame': 'Baseline', 'description': 'The EQ-5D-5L is a standardized questionnaire used as a measure of health-related quality of life. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression, on a five-level scale (no problem, slight problems, moderate problems, severe problems, unable to). The second part consist in a visual analogic scale about global health of the participant and provide a value from 0 to 100 with high value representing a good health.'}, {'measure': 'Fear-Avoidance Component Scale (FACS) score', 'timeFrame': 'Baseline', 'description': 'The fear-avoidance component scale is used to measure the major fear-avoidance signs in painful conditions. It includes 20 items evaluated on a 5-point Likert scale. The total score is from 0 to 100 with 5 severity levels: 0-20 subclinical, 21-40 low, 41-60 moderate, 61-80 severe, and extreme 81-100.'}, {'measure': 'Pain catastrophizing scale (PCS) score', 'timeFrame': 'Baseline', 'description': 'Catastrophism was evaluated with the pain catastrophizing scale. It includes 13 items evaluated on a 4-point Likert scale and divided into 3 dimensions: magnification, rumination, and helplessness. A high score corresponds to a high level of catastrophism. The total score ranges from 0 to 52 with a cut-off score of 30 for a significant catastrophism level.'}, {'measure': 'Hospital Anxiety and Depression scale (HAD) score', 'timeFrame': 'Baseline', 'description': 'The Hospital Anxiety and Depression scale (HAD) includes 14 items, 7 for anxiety and 7 for depression validated in French. Each item is rated from 0 to 3 and the scores for each dimension range from 0 to 21. Cut-off scores were established with 8-10 being uncertain symptomatology and above 10 being definite symptomatology.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinesiophobia', 'Low back pain', 'Posturography'], 'conditions': ['Non-specific Chronic Low Back Pain', 'Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers.\n\nThe main questions it aims to answer are :\n\nDo participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? Is the postural response correlated with the level of kinesiophobia? Participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General population', 'genderDescription': 'Male/Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 55\n* Non-specific chronic low back pain for the concerned group\n\nExclusion Criteria:\n\n* Low back pain for 0 to 3 months\n* Unable to stand 1 minute without technical aid\n* Neurological, motor or cognitive know impairment\n* BMI \\> 30'}, 'identificationModule': {'nctId': 'NCT06669767', 'acronym': 'ICOR', 'briefTitle': 'Behavioral Indicators of Pain Representation', 'organization': {'class': 'OTHER', 'fullName': 'Universite de Picardie Jules Verne'}, 'officialTitle': 'Behavioral Indicators of Pain Representation', 'orgStudyIdInfo': {'id': 'IRB00012476_2024_10_07_328'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-specific chronic low back pain', 'description': 'Participants with non-specific chronic low back pain (\\>3 months).'}, {'label': 'Control group', 'description': 'Healthy volunteers, without any low back pain.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80025', 'city': 'Amiens', 'country': 'France', 'facility': 'Université de Picardie Jules Verne', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Thierry LELARD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universite de Picardie Jules Verne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universite de Picardie Jules Verne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research engineer', 'investigatorFullName': 'Adrien Hakimi', 'investigatorAffiliation': 'Universite de Picardie Jules Verne'}}}}