An observational study in Residual Limb Pain, Post-Traumatic Limb Pain and Extremity Trauma, sponsored by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans). Completed at 1 site in Ukraine. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) · Observational
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.
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 100 is above the median of 67 across 25 observational studies indexed under Phantom Limb.
Browse Phantom Limb studies →Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Chronic limb pain at 6 months
2\. 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)
Time frame: 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.
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
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.
Time frame: 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury
Plan to share: 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.
Supporting information: Study protocol, Clinical study report
Time frame: Beginning 6 months after publication of the primary results and available for 5 years thereafter.
Access criteria: De-identified data will be available to qualified researchers upon approval of a research proposal and signing of a data use agreement. Data will be shared securely; no identifiable information will be provided.
Data sharing details ↗ · edu.superhumans.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)