Chronic PainFRSTPGaM-EWNCT05485311
The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain
An observational study of Chronic Pain, run by Bogomolets National Medical University at 1 site in Ukraine.
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. 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
- How many people
- 2,215 participants
- Where
- 1 siteUkraine
- Study dates
- 24 Feb 2022to 24 Jul 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: all patients were injured during hostilities
Who may be able to join
- the presence of gunshot and mine-explosive injuries
Who cannot join
- absence of gunshot and mine-explosive injuries
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 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.
Read the detailed 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.
- Conditions
- Chronic Pain
- Being tested
- visual analog scale
- Keywords
- chronic pain, surgical treatment, wounds
- Medical subject headings
- Chronic Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual analog scaleOther
Also called neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4)., Chaban Quality of Life Scale, The Hospital Anxiety and Depression Scale (HADS), Mississippi PTSD scale (military version)
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.
| 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. Receives: Other: visual analog scale | |
| prospective study | Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022 Receives: Other: visual analog scale |
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
Measured: 12 months
Didier Bouhassiraa DN4
4 or more points (a neuropathic pain component is present)
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
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
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 posted3 Aug 2022
- Study start24 Feb 2022
- Primary completion24 May 2022
- Study completion24 Jul 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
- Cross-sectional
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485311
- Sponsor's protocol ID
- №158.23.05.2022
- Acronym
- FRSTPGaM-EW
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I plan to share
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain
- ClinicalTrials.gov ID
- NCT05485311
- Acronym / sponsor ID
- FRSTPGaM-EW / №158.23.05.2022
- Conditions
- Chronic Pain
- Keywords
- chronic pain, surgical treatment, wounds
- 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 Jul 2022 (actual)
- First posted
- 3 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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective analysis | – | Other: visual analog scaleA 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. |
| prospective study | – | Other: visual analog scaleRecruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients were injured during hostilities
Key inclusion criteria (1 listed)
- the presence of gunshot and mine-explosive injuries
Key exclusion criteria (1 listed)
- absence of gunshot and mine-explosive injuries
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 scaleAlso: neuropathic pain Didier Bouhassiraa, Nadine Attala et al. Pain, 2005, 114: 29-36 (DN4)., Chaban Quality of Life Scale, The Hospital Anxiety and Depression Scale (HADS), Mississippi PTSD scale (military version)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. | Other | prospective study, retrospective analysis |
Primary outcome
visual analog scale
Time frame: 12 months
from 0 to 10 points
Didier Bouhassiraa DN4
Time frame: 12 months
4 or more points (a neuropathic pain component is present)
The Hospital Anxiety and Depression Scale
Time frame: 12 months
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
Chaban Quality of Life Scale
Time frame: 12 months
up to 56 inclusive - a very low level 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high
Mississippi PTSD scale (military version)
Time frame: 12 months
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
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 3 Aug 2022.
- Individual participant dataSharing planned: Undecided. I plan to share
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 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 3 Aug 2022.