Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-26 @ 7:48 AM
Study NCT ID:
NCT05478668
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D014948', 'term': 'Wounds, Gunshot'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014950', 'term': 'Wounds, Penetrating'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2215}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': '1 year', 'description': 'evaluation of the number of points'}, {'measure': 'Didier Bouhassiraa DN4', 'timeFrame': '1 year', 'description': 'evaluation of the number of points'}, {'measure': 'The Hospital Anxiety and Depression Scale', 'timeFrame': '1 year', 'description': 'evaluation of the number of points'}, {'measure': 'Chaban Quality of Life Scale', 'timeFrame': '1 year', 'description': 'evaluation of the number of points'}, {'measure': 'Mississippi PTSD scale (military version)', 'timeFrame': '1 year', 'description': 'evaluation of the number of points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic pain, gunshot wounds, mine-explosive wounds'], 'conditions': ['Chronic Pain, Widespread']}, 'descriptionModule': {'briefSummary': '82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity in these patients may improve their treatment outcomes.', 'detailedDescription': 'The study of predictors of pain chronicity in patients with gunshot and mine-explosive wounds requires in-depth study, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions have their own characteristics. Since pain becomes chronic in 82.1%, the data of our study will play an important role in preventing the chronicity of pain.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations.\n\nA retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.\n\nRecruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the presence of gunshot and mine-explosive injuries\n\nExclusion Criteria:\n\n* absence of gunshot and mine-explosive injuries'}, 'identificationModule': {'nctId': 'NCT05478668', 'acronym': 'PPСPGM-EW', 'briefTitle': 'Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Bogomolets National Medical University'}, 'officialTitle': 'Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds', 'orgStudyIdInfo': {'id': '№158, 2022.23.05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'retrospective analysis', 'description': 'A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury. In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction scale The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.', 'interventionNames': ['Other: visual analog scale']}, {'label': 'prospective study', 'description': 'Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients with gunshot wounds were evacuated to the stage of treatment - the National Military Medical Clinical Center "Main Military Clinical Hospital". The research was conducted using the same methods as during the retrospective analysis. The exception was the study period during treatment at the military medical clinical center: here it was 14 days.', 'interventionNames': ['Other: visual analog scale']}], 'interventions': [{'name': 'visual analog scale', 'type': 'OTHER', 'otherNames': ['neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4).', 'Chaban Quality of Life Scale', 'The Hospital Anxiety and Depression Scale', 'Mississippi scale of post-traumatic stress disorders (military version) (MS PTSD (m))'], 'description': 'In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.', 'armGroupLabels': ['prospective study', 'retrospective analysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Bogomolets National Medical University, Ministry of Health of Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'I plan to share'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bogomolets National Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'I am obtaining the scientific degree of Doctor of Medical Sciences at the Department of Surgery, Anesthesiology and Intensive Care', 'investigatorFullName': "Vasyl' Horoshko", 'investigatorAffiliation': 'Bogomolets National Medical University'}}}}