Predictors of Treatment Failure Pain Among Patients Gunshot Wounds (PTFPAPGW)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: visual analog scale (VAS).

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.

• Study Type: Observational
• Enrollment (Actual): 2215

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Bogomolets National Medical University, Ministry of Health of Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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

Description

Inclusion Criteria:

• presence of gunshot wounds during hostilities, male gender

Exclusion Criteria:

• absence of gunshot wounds during hostilities, other sex

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	from 0 to 10 points (the intensity of pain is determined)	12 months
Didier Bouhassiraa DN4	the number of points 4 or more indicates that the patient has a neuropathic pain component	12 months
The Hospital Anxiety and Depression Scale	more than 7 points indicates the presence of anxiety/depression	12 months
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	12 months
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	12 months

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University
• Investigators: Principal Investigator: Vasyl' Horoshko, PhD, Bogomolets National Medical University, Ministry of Health of Ukraine

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Wounds, Penetrating; Chronic Pain; Wounds, Gunshot
• Other Study ID Numbers: №158, 23.05.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No