Chronic Pain, WidespreadPPСPGM-EWNCT05478668
Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds
An observational study of Chronic Pain, Widespread, run by Bogomolets National Medical University at 1 site in Ukraine.
Trial summary
82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity 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, Widespread
- What is being tested?
- visual analog scale
- 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: The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations. 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. 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.
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
82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity in these patients may improve their treatment outcomes.
Read the detailed description
The study of predictors of pain chronicity in patients with gunshot and mine-explosive 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 pain becomes chronic in 82.1%, the data of our study will play an important role in preventing the chronicity of pain.
- Conditions
- Chronic Pain, Widespread
- Being tested
- visual analog scale
- Keywords
- Chronic pain, gunshot wounds, mine-explosive wounds
- Medical subject headings
- Chronic Pain, Wounds, Gunshot
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, Mississippi scale of post-traumatic stress disorders (military version) (MS PTSD (m))
In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). 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. In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction scale The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale. 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. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients 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 was the study period during treatment at the military medical clinical center: here it was 14 days. 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
evaluation of the number of points
Measured: 1 year
Didier Bouhassiraa DN4
evaluation of the number of points
Measured: 1 year
The Hospital Anxiety and Depression Scale
evaluation of the number of points
Measured: 1 year
Chaban Quality of Life Scale
evaluation of the number of points
Measured: 1 year
Mississippi PTSD scale (military version)
evaluation of the number of 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 posted28 Jul 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 Pain, WidespreadStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478668
- Sponsor's protocol ID
- №158, 2022.23.05
- Acronym
- PPСPGM-EW
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 2 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds
- ClinicalTrials.gov ID
- NCT05478668
- Acronym / sponsor ID
- PPСPGM-EW / №158, 2022.23.05
- Conditions
- Chronic Pain, Widespread
- Keywords
- Chronic pain, gunshot wounds, mine-explosive 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 May 2022 (actual)
- First posted
- 28 Jul 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.
82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity in these patients may improve their treatment outcomes.
Detailed description
The study of predictors of pain chronicity in patients with gunshot and mine-explosive 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 pain becomes chronic in 82.1%, the data of our study will play an important role in preventing the chronicity of pain.
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 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. In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction scale The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). Satisfaction with treatment results was studied using the Chaban Quality of Life Scale. |
| 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. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv. All patients 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 was the study period during treatment at the military medical clinical center: here it was 14 days. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations. 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. 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.
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, Mississippi scale of post-traumatic stress disorders (military version) (MS PTSD (m))In all patients, the assessment of anesthetic risk was carried out according to the ASA scale. The basic tool for pain intensity research was a visual analog scale. Intervals between analgesia were also studied. The study of the neuropathic component of pain was carried out using the Didier Bouhassiraa neuropathic pain diagnostic questionnaire. Study of the presence of an acute stress reaction The Hospital Anxiety and Depression Scale. Research on the presence of post-traumatic stress disorders was carried out using the Mississippi scale of post-traumatic stress disorders (military version). 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: 1 year
evaluation of the number of points
Didier Bouhassiraa DN4
Time frame: 1 year
evaluation of the number of points
The Hospital Anxiety and Depression Scale
Time frame: 1 year
evaluation of the number of points
Chaban Quality of Life Scale
Time frame: 1 year
evaluation of the number of points
Mississippi PTSD scale (military version)
Time frame: 1 year
evaluation of the number of 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 2 Aug 2022.
- Individual participant dataSharing planned: Undecided. I plan to share
Related trials for Chronic Pain, Widespread
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Recruiting
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
Chronic Pain, Chronic Pain Syndrome
RecruitingObservational study
Thoracolumbar Fascia Thickness in Women With Fibromyalgia
Fibromyalgia
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, Widespread, 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 2 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: 1 year). 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 2 Aug 2022.