Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder

Gunshot Entry Wound Clinical Trial

Official title:

Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689022
• Other study ID #: BogomoletsNMU
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The 82.1% treatment failure of post-traumatic stress disorder(PTSD), associated with gunshot wounds, is related to high incidence of chronic pain syndrome as well as resistance to the PTSD treatment. Defining treatment failure predictors among the PTSD patients with gunshot extremity wounds and the following therapy would improve treatment outcomes.

Description:

It has been noted that the PTSD in military combatants results from their direct participation in military actions. The study revealed that if a military combatant was wounded during the action operation, his emotional and subjective feelings will 100% lead to the PTSD. Other scientists state about the PTSD remote treatment failure in 80% of the military combatants. The study evidences about 82.1% of the PTSD m-related wounds treatment failure, which was essential for the subsequent studies. Some authors state about treatment effectiveness of psychopharmacological drugs and psychotherapy, which is rather questionable. Traumas and somatic diseases in the PTSD patients are known to accumulate their negative effects. So, definition of the PTSD treatment failure predictors may improve treatment outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: October 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• gunshot wounds
• post-traumatic stress disorder
• patients who need anesthesia

Exclusion Criteria:

• the patient has no post-traumatic stress disorder
• the patient has no gunshot wounds

Related Conditions & MeSH terms

• Gunshot Entry Wound
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries
• Wounds, Gunshot

Intervention

Behavioral:
• Mississippi Scale for Combat-Related PTSD (M-PTSD)
The treatment outcome rate was assessed by the Mississippi Scale for Combat-Related PTSD (M-PTSD). A positive outcome rate is represented with the patient post-discharge positive coping, which corresponds to 94-58 points, observed in 39 patients (17.9%). A treatment failure is regarded as the absent PTSD treatment effect after discharge, which corresponds to 148-113 points, observed in 5 patients (2.3%) and psychic disorders, which correspond to 112-95 points, observed in 174 patients (79,8%).

Diagnostic Test:
• visual analogue scale (VAS)
pain intensity
• Douleur Neuropathique 4 questions (DN4)
neuropathic pain component

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vasyl' Horoshko	Bogomolets National Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mississippi Scale for Combat-Related PTSD (M-PTSD)	The treatment outcome rate was assessed by the Mississippi Scale for Combat-Related PTSD (M-PTSD). A positive outcome rate is represented with the patient post-discharge positive coping, which corresponds to 94-58 points. A treatment failure is regarded as the absent PTSD treatment effect after discharge, which corresponds to 148-113 points and psychic disorders, which correspond to 112-95 points.	1 year