Predictors of Treatment Failure Pain Among Patients Gunshot Wounds

Chronic Pain Clinical Trial

— PTFPAPGW  

Official title:

Predictors of Treatment Failure Pain Among Patients Gunshot Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05482061
• Other study ID #: ?158, 23.05.2022
• Status: Completed
• Start date: February 24, 2022
• Est. completion date: May 24, 2022

Study information

• Verified date: July 2022
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2215
• Est. completion date: May 24, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• presence of gunshot wounds during hostilities, male gender

Exclusion Criteria:

• absence of gunshot wounds during hostilities, other sex

Related Conditions & MeSH terms

• Chronic Pain
• Wounds, Gunshot

Intervention

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.

Locations

Country	Name	City	State
Ukraine	Bogomolets National Medical University, Ministry of Health of Ukraine	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

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