About this trial
Persistent residual limb pain is common after traumatic amputation and significantly impairs rehabilitation and prosthetic use. Postoperative stump infection may contribute to peripheral nerve sensitization, scar fibrosis, and long-term pain persistence. This prospective cohort study aims to determine whether early post-amputation stump infection independently predicts persistent clinically significant residual limb pain at 3 and 6 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Traumatic upper or lower limb amputation
Enrollment within 4 weeks after surgery
Ability to provide informed consent
Disqualifiers
Pre-existing chronic pain in the affected limb
Severe cognitive impairment
Terminal illness limiting follow-up
Refusal or inability to complete follow-up assessments
Trial population
The study population will consist of adult patients (≥18 years) undergoing traumatic upper or lower limb amputation following blast-related, drone-related, or other high-energy injuries. Participants will be enrolled within 4 weeks after primary amputation surgery and followed prospectively for 6 months. The population represents individuals at risk of developing persistent residual limb pain during the early postoperative and rehabilitation period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Persistent Clinically Significant Residual Limb Pain
Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.
Secondary outcomes
Persistent Residual Limb Pain at 6 Months
NRS ≥4 at rest or during movement at 6 months after amputation.
Locations
Sponsors and contacts
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