NCT05485285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

August 1, 2022

Last Update Submit

July 25, 2023

Conditions

Keywords

pain, wounds, stages of treatment

Outcome Measures

Primary Outcomes (5)

  • visual analog scale

    from 0 to 10 points

    12 months

  • Didier Bouhassiraa DN4

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

    12 months

  • The Hospital Anxiety and Depression Scale

    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

    12 months

  • Chaban Quality of Life Scale

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

    12 months

  • Mississippi PTSD scale (military version)

    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

    12 months

Study Arms (2)

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

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

Interventions

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.

Also known as: neuropathic pain Didier Bouhassiraa (DN4)., Chaban Quality of Life Scale, The Hospital Anxiety and Depression Scale (HADS), Mississippi PTSD scale (military version)
prospective studyretrospective analysis

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients were injured during hostilities

You may qualify if:

  • the presence of gunshot wounds

You may not qualify if:

  • no gunshot wounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bogomolets National Medical University, Ministry of Health of Ukraine

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Chronic PainPainWounds and Injuries

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief researcher

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

February 24, 2022

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations