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CompletedNCT05482061PTFPAPGWUpdated Aug 1, 2022

Predictors of Treatment Failure Pain Among Patients Gunshot Wounds

An observational study in Chronic Pain, sponsored by Bogomolets National Medical University. Completed at 1 site in Ukraine. Open to male participants. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Bogomolets National Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,215
Sex
Male
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Study summary

In patients with gunshot wounds during hostilities in Ukraine, 76.9% have negative results of pain treatment, which leads to its chronicity. Identifying predictors of negative pain outcomes in these patients may improve their treatment outcomes.

Read the detailed description

One of the strongest factors that has a psychological impact on a person is war and conditions in which injury occurs, conditions in which pain occurs. A gunshot wound received during the war in the conditions of hostilities becomes the reason for the indisputable association of pain sensations with the events in which the patient was injured. It is pain and memories, memories and pain that cause the development of states with self-destructive behavior. According to statistics, gunshot wounds account for 54-70%. Gunshot wounds to the chest during anti-terrorist operations/OOS make up 7.4-11.7%, shrapnel wounds prevail here - 72.2%, explosive wounds - 17.5%, bullet wounds - 10.3%, and lethality - 12.2 -25%. According to the data of the Command of the Medical Forces of the Armed Forces of Ukraine, in the structure of gunshot injuries, 64% are injuries to the limbs: of them, 74.8% are soft tissues, 25.2% are gunshot fractures, bone defects are noted in 11.6% of patients, and wounded.

The study of predictors of negative results of pain treatment in patients with gunshot 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 in 76.9% 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.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 2,215 is above the median of 126 across 688 observational studies indexed under Chronic Pain.

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Lead sponsor

Bogomolets National Medical University is the lead sponsor of 37 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

1049 patients with gunshot wounds during hostilities were retrospectively studied. 1166 patients with gunshot wounds during hostilities were prospectively studied

Inclusion criteria

  • presence of gunshot wounds during hostilities, male gender

Exclusion criteria

Exclusion Criteria:

  • absence of gunshot wounds during hostilities, other sex
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,215 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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. The basic tool for pain intensity research was the VAS. The study of the neuropathic component of pain was carried out using the DN4. Study of the presence of an acute stress reaction - anamnesis + HADS. The diagnosis of ASR was established by a psychiatrist upon admission to the military mobile hospital. The presence of post-traumatic stress disorders (PTSD) was investigated using the Mississippi scale of post-traumatic stress disorders (military version). The presence of PTSD according to the MS PTSD (c). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.

    Other: visual analog scale (VAS).

  • 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 who took part in the study 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 is the study period during treatment at the military medical clinical center: here it was 14 days. In all patients with gunshot wounds, the outcome and effectiveness of pain management were assessed using the Visual Analogue Scale (VAS) and the Diagnostic Questionnaire for the Detection of the Neuropathic Pain Component Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4).

    Other: visual analog scale (VAS).

Interventions

  • Othervisual analog scale (VAS).

    The basic tool for pain intensity research was the VAS: 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; 5) at the rehabilitation stage. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the diagnostic DN4: military mobile hospital, a military medical clinical center, then at the time of discharge from a military medical clinical center. Study of the presence of an acute stress reaction - anamnesis + The Hospital Anxiety and Depression Scale. Satisfaction with treatment results was studied using the Chaban Quality of Life Scale.

    Also known as: neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4)., The Hospital Anxiety and Depression Scale (HADS), Mississippi scale of post-traumatic stress disorders (military version), Satisfaction with treatment results was studied using the Chaban Quality of Life Scale

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What researchers measure

Primary outcomes

  1. visual analog scale

    from 0 to 10 points (the intensity of pain is determined)

    Time frame: 12 months

  2. Didier Bouhassiraa DN4

    the number of points 4 or more indicates that the patient has a neuropathic pain component

    Time frame: 12 months

  3. The Hospital Anxiety and Depression Scale

    more than 7 points indicates the presence of anxiety/depression

    Time frame: 12 months

  4. Mississippi PTSD scale (military version)

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

    Time frame: 12 months

  5. Chaban Quality of Life Scale

    assesses quality of life and satisfaction with treatment results up to 56 points - very low 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high

    Time frame: 12 months

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Study locations

1 site
  • Bogomolets National Medical University, Ministry of Health of Ukraine
    Kyiv, Ukraine
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05482061
Lead sponsor
Bogomolets National Medical University
Responsible party
Vasyl' Horoshko (Principal Investigator, Bogomolets National Medical University) — Principal investigator
First posted
Aug 1, 2022
Start date
Feb 24, 2022
Primary completion
May 24, 2022
Completion
May 24, 2022
Last update
Aug 1, 2022

Study contacts

Vasyl' Horoshko, PhD
principal investigator · Bogomolets National Medical University, Ministry of Health of Ukraine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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