The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain

Chronic Pain Clinical Trial

— FRSTPGaM-EW  

Official title:

The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485311
• Other study ID #: ?158.23.05.2022
• Status: Completed
• Start date: February 24, 2022
• Est. completion date: July 24, 2022

Study information

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

Clinical Trial Summary

In 82.1% of patients with gunshot and mine-explosive injuries, the pain becomes chronic. The impact of the results of surgical treatment on the processes of chronic pain in this category of patients remains insufficiently studied. Therefore, the study of such a factor will be important to improve the results of pain treatment.

Description:

The influence of the results of surgical treatment in patients with gunshot and mine-explosive wounds on the formation of chronic pain needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

• absence of gunshot and mine-explosive injuries

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• visual analog scale
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.

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	12 months
Primary	Didier Bouhassiraa DN4	4 or more points (a neuropathic pain component is present)	12 months
Primary	The Hospital Anxiety and Depression Scale	0-7 is the norm 8-13 - mild depressive disorders 14-18 - depressive disorders of medium severity 19-22 - severe depressive disorders 23 and more - depressive disorders of a very severe degree of severity	12 months
Primary	Chaban Quality of Life Scale	up to 56 inclusive - a very low level 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high	12 months
Primary	Mississippi PTSD scale (military version)	the mean values of the total score are 76±18 for well-adjusted servicemen, 86±26 for servicemen with mental disorders, and 130±18 for those with PTSD	12 months