Chronic PainPTFPAPGWNCT05482061
Predictors of Treatment Failure Pain Among Patients Gunshot Wounds
An observational study of Chronic Pain, run by Bogomolets National Medical University at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- visual analog scale (VAS).
- How many people
- 2,215 participants
- Where
- 1 siteUkraine
- Study dates
- 24 Feb 2022to 24 May 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: 1049 patients with gunshot wounds during hostilities were retrospectively studied. 1166 patients with gunshot wounds during hostilities were prospectively studied
Who may be able to join
- presence of gunshot wounds during hostilities, male gender
Who cannot join
- absence of gunshot wounds during hostilities, other sex
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Bogomolets National Medical University, Ministry of Health of Ukraine
Kyiv
About this study
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.
Read the detailed 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.
- Conditions
- Chronic Pain
- Being tested
- visual analog scale (VAS).
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual analog scale (VAS).Other
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| retrospective analysis | A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. 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. The basic tool for pain intensity research was the VAS. The study of the neuropathic component of pain was carried out using the DN4. Study of the presence of an acute stress reaction - anamnesis + HADS. The diagnosis of ASR was established by a psychiatrist upon admission to the military mobile hospital. The presence of post-traumatic stress disorders (PTSD) was investigated using the Mississippi scale of post-traumatic stress disorders (military version). The presence of PTSD according to the MS PTSD (c). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale. Receives: Other: visual analog scale (VAS). | |
| prospective study | Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients who took part in the study with gunshot wounds were evacuated to the stage of treatment - the National Military Medical Clinical Center "Main Military Clinical Hospital". The research was conducted using the same methods as during the retrospective analysis. The exception is the study period during treatment at the military medical clinical center: here it was 14 days.
In all patients with gunshot wounds, the outcome and effectiveness of pain management were assessed using the Visual Analogue Scale (VAS) and the Diagnostic Questionnaire for the Detection of the Neuropathic Pain Component Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4). Receives: Other: visual analog scale (VAS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
from 0 to 10 points (the intensity of pain is determined)
Measured: 12 months
Didier Bouhassiraa DN4
the number of points 4 or more indicates that the patient has a neuropathic pain component
Measured: 12 months
The Hospital Anxiety and Depression Scale
more than 7 points indicates the presence of anxiety/depression
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start24 Feb 2022
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,215 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasyl' Horoshko, Bogomolets National Medical University
- Investigators
- Vasyl' Horoshko, PhD, Principal investigator, Bogomolets National Medical University, Ministry of Health of Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482061
- Sponsor's protocol ID
- №158, 23.05.2022
- Acronym
- PTFPAPGW
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Failure Pain Among Patients Gunshot Wounds
- ClinicalTrials.gov ID
- NCT05482061
- Acronym / sponsor ID
- PTFPAPGW / №158, 23.05.2022
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,215 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 1 Aug 2022 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective analysis | – | Other: visual analog scale (VAS).A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. 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. The basic tool for pain intensity research was the VAS. The study of the neuropathic component of pain was carried out using the DN4. Study of the presence of an acute stress reaction - anamnesis + HADS. The diagnosis of ASR was established by a psychiatrist upon admission to the military mobile hospital. The presence of post-traumatic stress disorders (PTSD) was investigated using the Mississippi scale of post-traumatic stress disorders (military version). The presence of PTSD according to the MS PTSD (c). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale. |
| prospective study | – | Other: visual analog scale (VAS).Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients who took part in the study with gunshot wounds were evacuated to the stage of treatment - the National Military Medical Clinical Center "Main Military Clinical Hospital". The research was conducted using the same methods as during the retrospective analysis. The exception is the study period during treatment at the military medical clinical center: here it was 14 days. In all patients with gunshot wounds, the outcome and effectiveness of pain management were assessed using the Visual Analogue Scale (VAS) and the Diagnostic Questionnaire for the Detection of the Neuropathic Pain Component Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4). |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1049 patients with gunshot wounds during hostilities were retrospectively studied. 1166 patients with gunshot wounds during hostilities were prospectively studied
Key inclusion criteria (1 listed)
- presence of gunshot wounds during hostilities, male gender
Key exclusion criteria (1 listed)
- absence of gunshot wounds during hostilities, other sex
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 |
|---|---|---|
| visual analog scale (VAS).Also: 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 ScaleThe 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 | prospective study, retrospective analysis |
Primary outcome
visual analog scale
Time frame: 12 months
from 0 to 10 points (the intensity of pain is determined)
Didier Bouhassiraa DN4
Time frame: 12 months
the number of points 4 or more indicates that the patient has a neuropathic pain component
The Hospital Anxiety and Depression Scale
Time frame: 12 months
more than 7 points indicates the presence of anxiety/depression
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
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
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 1 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Vasyl' Horoshko, PhD principal investigator
Bogomolets National Medical University, Ministry of Health of Ukraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Bogomolets National Medical University at 1 site in Ukraine.
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 1 inclusion and 1 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
visual analog scale (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022.