PTFPAPM-EW: Predictors of Treatment Failure Pain Among Patients With Mine-explosive Wounds

Sponsor
Bogomolets National Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05478655
Collaborator
(none)
1,166
1
2.9
398.8

Study Details

Study Description

Brief Summary

Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They are characterized by significant damage resulting in high intensity pain. In patients who received mine-explosive injuries in the conditions of hostilities, such pain has its own unique features. It is necessary to pay more attention to the problem of pain treatment in patients of this category, because about 87.2% of cases have negative results of treatment - it becomes chronic.

Condition or Disease Intervention/Treatment Phase
  • Other: visual analog scale

Detailed Description

The peculiarities of pain in patients with mine-explosive wounds depending on the localization of the wound at the stages of treatment need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Since in 87.2% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1166 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Predictors of Treatment Failure Pain Among Patients With Mine-explosive Wounds
Actual Study Start Date :
Feb 24, 2022
Actual Primary Completion Date :
May 24, 2022
Actual Study Completion Date :
May 24, 2022

Arms and Interventions

Arm Intervention/Treatment
retrospective analysis

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 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.The study of the neuropathic component of pain was carried out using the diagnostic questionnaire for the detection of neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36. Study of the presence of an acute stress reaction scale The Hospital Anxiety and Depression Scale. The presence of post-traumatic stress disorders was studied using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with the results of treatment was studied using the Chaban Quality of Life Scale.

Other: visual analog scale
VAS was studied: 1) before and after anesthesia - at the stage of the medical and nursing brigade, military mobile hospital, military medical clinical center; 2) at the stage of the medical and nursing team - within 2 days; 3) at the stage of the military mobile hospital - within 5 days; 4) at the stage of the military medical clinical center - within 7 days, at the time of discharge from the hospital and further 1, 3, 6, 12 months after the injury; 5) at the rehabilitation stage. Intervals between analgesia were also studied.
Other Names:
  • neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4).
  • ASA
  • The Hospital Anxiety and Depression Scale
  • Mississippi PTSD scale (military version)
  • Chaban Quality of Life Scale
  • prospective study

    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.

    Other: visual analog scale
    VAS was studied: 1) before and after anesthesia - at the stage of the medical and nursing brigade, military mobile hospital, military medical clinical center; 2) at the stage of the medical and nursing team - within 2 days; 3) at the stage of the military mobile hospital - within 5 days; 4) at the stage of the military medical clinical center - within 7 days, at the time of discharge from the hospital and further 1, 3, 6, 12 months after the injury; 5) at the rehabilitation stage. Intervals between analgesia were also studied.
    Other Names:
  • neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4).
  • ASA
  • The Hospital Anxiety and Depression Scale
  • Mississippi PTSD scale (military version)
  • Chaban Quality of Life Scale
  • Outcome Measures

    Primary Outcome Measures

    1. visual analog scale [12 months]

      evaluation of the number of points

    2. Didier Bouhassiraa DN4 [12 months]

      evaluation of the number of points

    3. The Hospital Anxiety and Depression Scale [12 months]

      evaluation of the number of points

    4. Chaban Quality of Life Scale [12 months]

      evaluation of the number of points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • chronic pain, mine-explosive wounds
    Exclusion Criteria:
    • absence of mine-explosive wounds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bogomolets National Medical University, Ministry of Health of Ukraine Kyiv Ukraine

    Sponsors and Collaborators

    • Bogomolets National Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vasyl' Horoshko, Chief researcher, Bogomolets National Medical University
    ClinicalTrials.gov Identifier:
    NCT05478655
    Other Study ID Numbers:
    • №158 23/05/2022
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vasyl' Horoshko, Chief researcher, Bogomolets National Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2022