Residual Limb PainKIN-LIMBNCT07432685
Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma
An observational study of Residual Limb Pain and Post-Traumatic Limb Pain, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
Trial summary
Combat-related extremity trauma frequently results in persistent pain, including neuropathic, residual limb, and phantom limb pain. The kinematics of injury-including energy level, direction of force, and dominant force components-may independently predict tissue deformation, nerve stress, and the transition from… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Residual Limb Pain, Post-Traumatic Limb Pain, Extremity Trauma
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 12 Mar 2026to 11 Oct 2026
- How long will I take part?
- 6 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study includes adults with acute combat-related extremity trauma presenting to participating trauma and rehabilitation centers in Ukraine. Eligible participants have upper and/or lower limb injuries resulting from combat-related mechanisms, including blunt trauma, penetrating (ballistic or shrapnel) injuries, blast-related injuries, hybrid (blast plus fragment) injuries, and traumatic amputations (partial or complete). Participants must be enrolled within 72 hours of injury and report acute limb pain with a Numeric Rating Scale (NRS) score ≥3 at baseline. The study population represents a real-world cohort of combat-injured adults at risk for persistent limb pain, neuropathic pain, residual limb pain, and phantom limb pain.
Who may be able to join
- Age ≥18 years
- Combat-related extremity trauma involving upper and/or lower limbs
- Blunt limb trauma
- Penetrating limb injury (ballistic or shrapnel)
- Blast-related limb injury
- Hybrid injury (blast plus fragment)
Show all 11Show fewer
- тTraumatic amputation (partial or complete)
- Baseline assessment performed within 72 hours of injury
- Acute limb pain with Numeric Rating Scale (NRS) score ≥3 at baseline
- Ability to provide informed consent
- Ability to participate in follow-up assessments
Who cannot join
- Inability to complete follow-up assessments
- Severe cognitive impairment preventing informed consent
- Declines participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KIN-LIMB Protocol V1.0. KIN-LIMB: Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma
Combat-related extremity trauma frequently results in persistent pain, including neuropathic, residual limb, and phantom limb pain. The kinematics of injury-including energy level, direction of force, and dominant force components-may independently predict tissue deformation, nerve stress, and the transition from acute to chronic- pain. This prospective observational cohort study will assess whether kinematics-only variables predict chronic pain outcomes after combat-related upper and lower limb injuries. Pain outcomes will include pain intensity, pain extent (surface/area), neuropathic pain features, and mechanical pain sensitivity measured using von Frey filaments.
Read the detailed description
Adults with combat-related limb trauma will be enrolled within 72 hours of injury. Baseline assessment will include a standardized kinematics classification documenting (1) energy class, (2) dominant direction of force, (3) dominant force component, and (4) kinematics severity grade (K0-K3). Participants will be followed at 6 weeks, 3 months, and 6 months. The primary endpoint is chronic limb pain at 3 months. Secondary endpoints include chronic pain at 6 months, pain area, neuropathic features, and mechanical pain thresholds using von Frey testing at standardized limb sites (injured and contralateral control). This is a non-interventional study; no treatment decisions are dictated by the protocol.
- Conditions
- Residual Limb Pain, Post-Traumatic Limb Pain, Extremity Trauma, Combat-Related Limb Injury, Phantom Limb Pain, Phantom Limb Pain After Amputation
- Keywords
- Chronic Pain, Residual pain, Extremity trauma;, combat injury, limb injury, amputation, mechanical pain threshold
- Medical subject headings
- Phantom Limb, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic limb pain at 3 months
Presence of chronic limb pain at 3 months following injury
Chronic limb pain is defined as persistent or recurrent pain localized to the anatomically injured limb, with an average Numeric Rating Scale (NRS) score ≥3 (0-10 scale) during the preceding 7 days at the 3-month follow-up.
Pain intensity will be assessed using a standardized 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain).
Participants will be categorized as:
Yes - chronic limb pain present (NRS ≥3)
No - chronic limb pain absent (NRS <3)
The primary analysis will evaluate the association between baseline injury kinematics variables (energy class, dominant force direction, dominant force component, and kinematics severity grade K0-K3) and the presence of chronic limb pain at 3 months.
Measured: Assessed at 3 months (90 days ± 14 days) after injury Pain assessment will be conducted during the scheduled 3-month follow-up visit (between Day 76 and Day 104 post-injury).
Secondary outcomes (3)
Chronic limb pain at 6 months
- Chronic Limb Pain at 6 Months
Secondary Outcome Measure:
Presence of chronic limb pain at 6 months following injury
Description:
Persistent or recurrent limb pain defined as an average Numeric Rating Scale (NRS) score ≥3 (0-10 scale) during the preceding 7 days at the 6-month follow-up visit.
Participants will be categorized as:
Yes - chronic limb pain present (NRS ≥3)
No - chronic limb pain absent (NRS <3)
Measured: 6 months (180 ± 21 days) after injury
Pain Intensity Over Time (Continuous NRS Score)
Secondary Outcome Measure:
Pain intensity measured using the Numeric Rating Scale (0-10)
Description:
Pain intensity assessed using a standardized 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain). The mean NRS score at each follow-up visit will be analyzed as a continuous variable.
Measured: Baseline (within 72 hours of injury), 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury
Pain extent measured as percentage of affected limb surface area
Pain distribution recorded using standardized digital limb body maps. Pain extent will be quantified using digital planimetry and expressed as percentage (%) of total limb surface area.
Measured: 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start12 Mar 2026
- Primary completion11 Oct 2026
- Study completion11 Oct 2026
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 Residual Limb 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
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432685
- Sponsor's protocol ID
- 091302026
- Acronym
- KIN-LIMB
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request. Data will include baseline kinematics variables, pain measures (NRS), pain extent, DN4 scores, and mechanical pain thresholds (von Frey), including amputation subgroup outcomes where applicable. Data will be shared after approval of a research proposal and execution of a data use agreement. No identifiable information will be disclosed. Data will be available beginning 6 months after publication of the primary results.
Publications
Burmistr I, Zaslansky R, Dmytriiev D, Kopf A. The Total Pain in Ukraine Study: How Does War Affect Civilians With a History of Chronic Pain? An Observational Study. Eur J Pain. 2026 Jan;30(1):e70185. doi: 10.1002/ejp.70185.
PubMed 41376178
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIN-LIMB Protocol V1.0. KIN-LIMB: Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma
- ClinicalTrials.gov ID
- NCT07432685
- Acronym / sponsor ID
- KIN-LIMB / 091302026
- Conditions
- Residual Limb Pain, Post-Traumatic Limb Pain, Extremity Trauma, Combat-Related Limb Injury, Phantom Limb Pain, Phantom Limb Pain After Amputation
- Keywords
- Chronic Pain, Residual pain, Extremity trauma;, combat injury, limb injury, amputation, mechanical pain threshold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)University, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 11 Oct 2026 (actual)
- Study completion
- 11 Oct 2026 (actual)
- First posted
- 25 Feb 2026 (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.
Combat-related extremity trauma frequently results in persistent pain, including neuropathic, residual limb, and phantom limb pain. The kinematics of injury-including energy level, direction of force, and dominant force components-may independently predict tissue deformation, nerve stress, and the transition from acute to chronic- pain. This prospective observational cohort study will assess whether kinematics-only variables predict chronic pain outcomes after combat-related upper and lower limb injuries. Pain outcomes will include pain intensity, pain extent (surface/area), neuropathic pain features, and mechanical pain sensitivity measured using von Frey filaments.
Detailed description
Adults with combat-related limb trauma will be enrolled within 72 hours of injury. Baseline assessment will include a standardized kinematics classification documenting (1) energy class, (2) dominant direction of force, (3) dominant force component, and (4) kinematics severity grade (K0-K3). Participants will be followed at 6 weeks, 3 months, and 6 months. The primary endpoint is chronic limb pain at 3 months. Secondary endpoints include chronic pain at 6 months, pain area, neuropathic features, and mechanical pain thresholds using von Frey testing at standardized limb sites (injured and contralateral control). This is a non-interventional study; no treatment decisions are dictated by the protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study includes adults with acute combat-related extremity trauma presenting to participating trauma and rehabilitation centers in Ukraine. Eligible participants have upper and/or lower limb injuries resulting from combat-related mechanisms, including blunt trauma, penetrating (ballistic or shrapnel) injuries, blast-related injuries, hybrid (blast plus fragment) injuries, and traumatic amputations (partial or complete). Participants must be enrolled within 72 hours of injury and report acute limb pain with a Numeric Rating Scale (NRS) score ≥3 at baseline. The study population represents a real-world cohort of combat-injured adults at risk for persistent limb pain, neuropathic pain, residual limb pain, and phantom limb pain.
Key inclusion criteria (11 listed)
- Age ≥18 years
- Combat-related extremity trauma involving upper and/or lower limbs
- Blunt limb trauma
- Penetrating limb injury (ballistic or shrapnel)
- Blast-related limb injury
Key exclusion criteria (3 listed)
- Inability to complete follow-up assessments
- Severe cognitive impairment preventing informed consent
- Declines participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic limb pain at 3 months
Time frame: Assessed at 3 months (90 days ± 14 days) after injury Pain assessment will be conducted during the scheduled 3-month follow-up visit (between Day 76 and Day 104 post-injury).
Presence of chronic limb pain at 3 months following injury Chronic limb pain is defined as persistent or recurrent pain localized to the anatomically injured limb, with an average Numeric Rating Scale (NRS) score ≥3 (0-10 scale) during the preceding 7 days at the 3-month follow-up. Pain intensity will be assessed using a standardized 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain). Participants will be categorized as: Yes - chronic limb pain present (NRS ≥3) No - chronic limb pain absent (NRS <3) The primary analysis will evaluate the association between baseline injury kinematics variables (energy class, dominant force direction, dominant force component, and kinematics severity grade K0-K3) and the presence of chronic limb pain at 3 months.
3 secondary outcomes
Chronic limb pain at 6 months
Time frame: 6 months (180 ± 21 days) after injury
Pain Intensity Over Time (Continuous NRS Score)
Time frame: Baseline (within 72 hours of injury), 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury
Pain extent measured as percentage of affected limb surface area
Time frame: 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury
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 16 Oct 2026.
- Results publication: PubMed 41376178Burmistr I, Zaslansky R, Dmytriiev D, Kopf A. The Total Pain in Ukraine Study: How Does War Affect Civilians With a History of Chronic Pain? An Observational Study. Eur J Pain. 2026 Jan;30(1):e70185. doi: 10.1002/ejp.70185.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request. Data will include baseline kinematics variables, pain measures (NRS), pain extent, DN4 scores, and mechanical pain thresholds (von Frey), including amputation subgroup outcomes where applicable. Data will be shared after approval of a research proposal and execution of a data use agreement. No identifiable information will be disclosed. Data will be available beginning 6 months after publication of the primary results.
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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 Residual Limb Pain and Post-Traumatic Limb Pain, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) 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 11 inclusion and 3 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 16 Oct 2026. 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?
Chronic limb pain at 3 months (time frame: Assessed at 3 months (90 days ± 14 days) after injury Pain assessment will be conducted during the scheduled 3-month follow-up visit (between Day 76 and Day 104 post-injury).). 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 NCT07432685, 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.