Gunshot Entry WoundNCT04689022
Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder
A study testing Mississippi Scale for Combat-Related PTSD (M-PTSD), visual analogue scale (VAS) and Douleur Neuropathique 4 questions (DN4) in people with Gunshot Entry Wound, run by Vasyl' Horoshko.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Gunshot Entry Wound
- What is being tested?
- Mississippi Scale for Combat-Related PTSD (M-PTSD), visual analogue scale (VAS) and Douleur Neuropathique 4 questions (DN4)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- gunshot wounds
- post-traumatic stress disorder
- patients who need anesthesia
Who cannot join
- the patient has no post-traumatic stress disorder
- the patient has no gunshot wounds
About this study
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.
Read the detailed 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.
- Conditions
- Gunshot Entry Wound
- Being tested
- Mississippi Scale for Combat-Related PTSD (M-PTSD), visual analogue scale (VAS), Douleur Neuropathique 4 questions (DN4)
- Keywords
- Post-traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mississippi Scale for Combat-Related PTSD (M-PTSD)Behavioural
Also called The PTSD progress and treatment effectiveness were estimated using the 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%).
visual analogue scale (VAS)Diagnostic test
Also called VAS
pain intensity
Douleur Neuropathique 4 questions (DN4)Diagnostic test
Also called DN4
neuropathic pain component
| Study group | Role | What they receive |
|---|---|---|
| Group І received general anesthesia (n=53) | Other | The sedation with constant rate infusion of 1% propofol, 1-4mg/kg/h, guided by Bispectral analysis (60-70 - for regional anesthesia and 40-60 - for the general one). 0.005% fentanyl analgesia was injected, 3-10 mkg/kg or 0.05-0.2 mkg/kg/min during induction; and 2-10 mkg/kg/h for maintaining analgesia, by periodic bolus injection 25-100 mkg or by permanent infusion.
The postoperative pain management of the I group patients was provided according to the local clinical protocol: paracetamol+/-non-steroid anti-inflammatory drugs +/-opioids.
The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions. Receives: Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4) |
| Group II received regional anesthesia: peripheral block was performed (n=73) | Other | The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected.
The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution.
The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions. Receives: Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4) |
| Group III received regional anesthesia with sedation (n=92) | Other | The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected.
The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution.
The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions. Receives: Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD); Diagnostic Test: visual analogue scale (VAS); Diagnostic Test: Douleur Neuropathique 4 questions (DN4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Apr 2014
- Primary completion30 Dec 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gunshot Entry WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 218 patients completed the study. The Mississippi Scale for Combat-Related PTSD (M-PTSD) was used for assessment of the treatment outcome rate. The risk relation between treatment failure and factors was assessed by a univariate or multivariate logistic regression method, with the model accuracy measured by the AUC - Area under the ROC curve. The odds ratio (OR) was considered for the qualitative factor assessment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vasyl' Horoshko
- Sponsor type
- University, hospital or other
- Collaborators
- Bogomolets National Medical University
- Responsible party
- Sponsor-investigator, Vasyl' Horoshko, Bogomolets National Medical University
- Investigators
- Iurii Kuchyn, MD, Study chair, National medical University named after O. O. Bogomolets, Kyiv, Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689022
- Sponsor's protocol ID
- BogomoletsNMU
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuchyn IL, Horoshko VR. Predictors of treatment failure among patients with gunshot wounds and post-traumatic stress disorder. BMC Anesthesiol. 2021 Oct 30;21(1):263. doi: 10.1186/s12871-021-01482-8.
PubMed 34717551
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04689022
- Acronym / sponsor ID
- BogomoletsNMU
- Conditions
- Gunshot Entry Wound
- Keywords
- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Vasyl' HoroshkoUniversity, hospital or other
- Collaborators
- Bogomolets National Medical University
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A total of 218 patients completed the study. The Mississippi Scale for Combat-Related PTSD (M-PTSD) was used for assessment of the treatment outcome rate. The risk relation between treatment failure and factors was assessed by a univariate or multivariate logistic regression method, with the model accuracy measured by the AUC - Area under the ROC curve. The odds ratio (OR) was considered for the qualitative factor assessment.
| Arm | Type | Receives |
|---|---|---|
| Group І received general anesthesia (n=53) | Other | Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD), Diagnostic Test: visual analogue scale (VAS), Diagnostic Test: Douleur Neuropathique 4 questions (DN4)The sedation with constant rate infusion of 1% propofol, 1-4mg/kg/h, guided by Bispectral analysis (60-70 - for regional anesthesia and 40-60 - for the general one). 0.005% fentanyl analgesia was injected, 3-10 mkg/kg or 0.05-0.2 mkg/kg/min during induction; and 2-10 mkg/kg/h for maintaining analgesia, by periodic bolus injection 25-100 mkg or by permanent infusion. The postoperative pain management of the I group patients was provided according to the local clinical protocol: paracetamol+/-non-steroid anti-inflammatory drugs +/-opioids. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions. |
| Group II received regional anesthesia: peripheral block was performed (n=73) | Other | Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD), Diagnostic Test: visual analogue scale (VAS), Diagnostic Test: Douleur Neuropathique 4 questions (DN4)The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected. The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions. |
| Group III received regional anesthesia with sedation (n=92) | Other | Behavioral: Mississippi Scale for Combat-Related PTSD (M-PTSD), Diagnostic Test: visual analogue scale (VAS), Diagnostic Test: Douleur Neuropathique 4 questions (DN4)The regional anesthesia was guided by ultrasound (apparatus Mindray DP-30 with linear array probe 5-10 MHz). A needle was inserted near the nerve roots and 20-30 ml of 0.5% bupivacaine was injected. The postoperative pain management - repeated peripheral block or prolonged regional anesthesia with 0.25% bupivacaine solution. The PTSD progress and treatment effectiveness were estimated using the Mississippi Scale for Combat-Related PTSD, anesthesia risks - the American Society of Anesthesiologists classification, pain intensity - the visual analogue scale, neuropathic pain component - the Douleur Neuropathique 4 questions. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- gunshot wounds
- post-traumatic stress disorder
- patients who need anesthesia
Key exclusion criteria (2 listed)
- the patient has no post-traumatic stress disorder
- the patient has no gunshot wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mississippi Scale for Combat-Related PTSD (M-PTSD)Also: The PTSD progress and treatment effectiveness were estimated using the 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%). | Behavioural | Group II received regional anesthesia: peripheral block was performed (n=73), Group III received regional anesthesia with sedation (n=92), Group І received general anesthesia (n=53) |
| visual analogue scale (VAS)Also: VASpain intensity | Diagnostic test | Group II received regional anesthesia: peripheral block was performed (n=73), Group III received regional anesthesia with sedation (n=92), Group І received general anesthesia (n=53) |
| Douleur Neuropathique 4 questions (DN4)Also: DN4neuropathic pain component | Diagnostic test | Group II received regional anesthesia: peripheral block was performed (n=73), Group III received regional anesthesia with sedation (n=92), Group І received general anesthesia (n=53) |
Primary outcome
Mississippi Scale for Combat-Related PTSD (M-PTSD)
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Derived from this study: PubMed 34717551Kuchyn IL, Horoshko VR. Predictors of treatment failure among patients with gunshot wounds and post-traumatic stress disorder. BMC Anesthesiol. 2021 Oct 30;21(1):263. doi: 10.1186/s12871-021-01482-8.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iurii Kuchyn, MD study chair
National medical University named after O. O. Bogomolets, Kyiv, Ukraine
Questions about this trial
What is this clinical trial studying?
A study testing Mississippi Scale for Combat-Related PTSD (M-PTSD), visual analogue scale (VAS) and Douleur Neuropathique 4 questions (DN4) in people with Gunshot Entry Wound, run by Vasyl' Horoshko.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mississippi Scale for Combat-Related PTSD (M-PTSD) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.