Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-08 @ 1:10 PM
Study NCT ID:
NCT02774694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2015-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Outcome of Interventional Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ROC-AUC for incidence of pain reduction>30% at 1 week', 'timeFrame': '1 week', 'description': 'Primary study outcome is the diagnostic accuracy of the NFR threshold, measured as area under the "receiver operating characteristic ROC" curve, for the following main pain management outcome:\n\n"pain reduction of 30% one week after the interventional procedure'}], 'secondaryOutcomes': [{'measure': 'ROC-AUC for incidence of pain reduction>30% at 1 month', 'timeFrame': '1 month', 'description': 'Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction\\>30% at 1 month'}, {'measure': 'ROC-AUC for incidence of pain reduction>30% at 3 months', 'timeFrame': '3 months', 'description': 'Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction\\>30% at 3 months'}, {'measure': 'ROC-AUC for incidence of pain reduction>30% at 6 months', 'timeFrame': '6 months', 'description': 'Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction\\>30% at 6 months'}, {'measure': 'ROC-AUC for physical functioning at 1 week', 'timeFrame': '1 week'}, {'measure': 'ROC-AUC for emotional functioning at 1 week', 'timeFrame': '1 week'}, {'measure': 'ROC-AUC for patient rating of improvement and satisfaction at 1 week', 'timeFrame': '1 week'}, {'measure': 'adverse events of interventional pain management', 'timeFrame': '1 week'}, {'measure': 'patient disposition at 1 week, 1,3, and 6 months', 'timeFrame': '6 months', 'description': 'The presence or unexcused absence of the patient at each consultation visit is noted'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nociceptive flexion reflex', 'interventional pain management'], 'conditions': ['Low Back Pain', 'Neck Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Specifically, the nociceptive reflex threshold will be investigated, which is a measure of central sensibilisation and thus a potentially important prognostic factor.', 'detailedDescription': 'Interventional pain management is resource-intensive and carries non-negligible risks. Not all patients profit equally from such procedures. For those who do not benefit, the risk of potential complications is futile, and the resources are wasted. Therefore, a possibility to distinguish responding patients from non-responders would be important.\n\nCentral pain sensitization has been related to poor outcome, and electrical pain and reflex thresholds are a good measure of pain hypersensitivity at least in chronic low back pain. Especially the nociceptive flexion reflex (NFR) threshold has been identified to correlate well with central pain hypersensibility. Successful interventional pain treatment has been shown to reverse central hypersensibility as measured by the NFR threshold.\n\nNFR threshold, in contrast to pain threshold, seems to be a measure independent of psychological factors. Thus the NFR threshold could give information independent of psychological factors in order to predict poor outcome of interventional pain management procedures.\n\nThe study will be a prospective observational trial of diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Included will be patients treated by the interventional pain management team of the department of anaesthesiology of the Geneva University Hospitals HUG', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with chronic low back or neck pain (duration \\>3 months)\n* scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation\n\nExclusion Criteria:\n\n* inability to understand the patient information or the study questionnaires\n* patients \\<18 years old\n* patients with implanted pacemakers or defibrillators'}, 'identificationModule': {'nctId': 'NCT02774694', 'acronym': 'POINTPM', 'briefTitle': 'Prediction of Outcome of Interventional Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Observational Study of the Nociceptive Flexion Reflex Threshold to Predict Outcome After Interventional Pain Management Procedures in Patients With Chronic Back and Neck Pain. A Study of Diagnostic Accuracy', 'orgStudyIdInfo': {'id': '15-072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observational cohort', 'description': 'patients undergoing interventional pain management procedures', 'interventionNames': ['Device: nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)']}], 'interventions': [{'name': 'nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)', 'type': 'DEVICE', 'otherNames': ['R3 reflex'], 'description': 'measurement of the NFR threshold using the "Paintracker" device', 'armGroupLabels': ['observational cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benno Rehberg-Klug, MD', 'role': 'CONTACT', 'email': 'benno.rehberg-klug@hcuge.ch', 'phone': '+41223723476'}, {'name': 'Stanislas Mathivon', 'role': 'CONTACT', 'email': 'stanislas.mathivon@hcuge.ch'}], 'overallOfficials': [{'name': 'Benno Rehberg-Klug, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benno Rehberg-Klug', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Médecin adjoint agrégé', 'investigatorFullName': 'Benno Rehberg-Klug', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}