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Completed

NCT Number: NCT05482061

Predictors of Treatment Failure Pain Among Patients Gunshot Wounds

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.

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Key information

Conditions

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

Sex eligibility

Male

Study type

Observational

Primary location

Bogomolets National Medical University, Ministry of Health of Ukraine

Kyiv, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presence of gunshot wounds during hostilities, male gender

Exclusion criteria

  • absence of gunshot wounds during hostilities, other sex

Treatment and study plan

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.

Other names: 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

Primary outcomes

  1. visual analog scale

    Time frame: 12 months

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

  2. Didier Bouhassiraa DN4

    Time frame: 12 months

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

  3. The Hospital Anxiety and Depression Scale

    Time frame: 12 months

    more than 7 points indicates the presence of anxiety/depression

  4. Mississippi PTSD scale (military version)

    Time frame: 12 months

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

  5. Chaban Quality of Life Scale

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Registry information

Acronym: PTFPAPGW

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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