Chronic Pain, Chronic Pain Due to Injury, Combat-Related Limb Injury, Extremity Trauma, Phantom Limb Pain, Phantom Limb Pain After Amputation, Post-Traumatic Limb Pain, Residual Limb Pain
Conditions
Keywords
Chronic Pain, Residual pain, Extremity trauma;, combat injury, limb injury, amputation, mechanical pain threshold
Brief 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 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.
Interventions
None listed
Sponsors
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Exclusion criteria
* Inability to complete follow-up assessments * Severe cognitive impairment preventing informed consent * Declines participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic limb pain at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Over Time (Continuous NRS Score) | Baseline (within 72 hours of injury), 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury | 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. |
| Chronic limb pain at 6 months | 6 months (180 ± 21 days) after injury | 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) |
| Pain extent measured as percentage of affected limb surface area | 6 weeks (±7 days), 3 months (90 ± 14 days), and 6 months (180 ± 21 days) after injury | 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. |
Countries
Ukraine
Outcome results
None listed