Predictors of Treatment Failure Pain Among Patients Gunshot Wounds

NCT05482061 | Completed

• 1 other identifier: №158, 23.05.2022
• Study Type: observational
• Target: 2,215
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

• 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

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. 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

visual analog scale (VAS). OTHER

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

prospective study; retrospective analysis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• presence of gunshot wounds during hostilities, male gender

You may not qualify if:

• absence of gunshot wounds during hostilities, other sex

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Bogomolets National Medical University, Ministry of Health of Ukraine

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vasyl' Horoshko, PhD

  Bogomolets National Medical University, Ministry of Health of Ukraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 1, 2022
• Study Start: February 24, 2022
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)