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FRSTPGaM-EW: The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain

Sponsor
Bogomolets National Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05485311
Collaborator
(none)
2,215
Enrollment
1
Location
4.9
Actual Duration (Months)
449.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In 82.1% of patients with gunshot and mine-explosive injuries, the pain becomes chronic. The impact of the results of surgical treatment on the processes of chronic pain in this category of patients remains insufficiently studied. Therefore, the study of such a factor will be important to improve the results of pain treatment.

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

Detailed Description

The influence of the results of surgical treatment in patients with gunshot and mine-explosive wounds on the formation of chronic pain needs 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. Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
2215 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain
Actual Study Start Date :
Feb 24, 2022
Actual Primary Completion Date :
May 24, 2022
Actual Study Completion Date :
Jul 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, within 12 months of the injury.

Other: visual analog scale
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.
Other Names:
  • 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 (HADS)
  • Mississippi PTSD scale (military version)

    		•
    prospective study

    Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022

    Other: visual analog scale
    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.
    Other Names:
  • 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 (HADS)
  • Mississippi PTSD scale (military version)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. visual analog scale [12 months]

      from 0 to 10 points

    2. Didier Bouhassiraa DN4 [12 months]

      4 or more points (a neuropathic pain component is present)

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

      0-7 is the norm 8-13 - mild depressive disorders 14-18 - depressive disorders of medium severity 19-22 - severe depressive disorders 23 and more - depressive disorders of a very severe degree of severity

    4. Chaban Quality of Life Scale [12 months]

      up to 56 inclusive - a very low level 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high

    5. Mississippi PTSD scale (military version) [12 months]

      the mean values of the total score are 76±18 for well-adjusted servicemen, 86±26 for servicemen with mental disorders, and 130±18 for those with PTSD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • the presence of gunshot and mine-explosive injuries
    Exclusion Criteria:
    • absence of gunshot and mine-explosive injuries

    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:
    NCT05485311
    Other Study ID Numbers:
    • №158.23.05.2022
    First Posted:
    Aug 3, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 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
    chronic pain, surgical treatment, wounds
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Aug 3, 2022