Patients with combat-related amputations frequently experience chronic neuroma pain that may interfere with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Current treatment approaches often provide only temporary pain relief.
Platelet-rich plasma (PRP) has emerged as a potential regenerative treatment option because of its possible effects on tissue healing, neuroinflammation, and peripheral nerve irritation. However, its role in the treatment of chronic neuroma pain after amputation remains unclear.
This prospective multicenter controlled study aims to compare ultrasound-guided PRP injection around the neuroma with ultrasound-guided local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.
Participants will undergo one of the two injection treatments and will be followed over time to evaluate changes in pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes.
The goal of the study is to evaluate the safety, feasibility, and potential clinical effectiveness of PRP injection for chronic neuroma pain following combat-related amputation.
Age ≥18 years
Combat-related limb amputation
Chronic neuroma pain lasting ≥3 months
Ultrasound-confirmed painful neuroma
Active infection at or near the injection site
Open wound preventing safe injection
Previous PRP injection for neuroma pain within 6 months
Previous neuroma surgery within 3 months
Parallel
Platelet-Rich Plasma (PRP) Injections
Biological/VaccineUltrasound-guided perineuroma platelet-rich plasma injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Local Anesthetic Injection
DrugUltrasound-guided perineuroma local anesthetic injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Chronic neuroma pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average neuroma-related pain during the previous 7 days on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Change from baseline will be analyzed. Scale Information: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate greater neuroma pain intensity and worse clinical outcomes.
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
Neuropathic pain characteristics will be assessed using the painDETECT Questionnaire (PD-Q), a validated patient-reported screening tool designed to identify neuropathic pain features. The questionnaire evaluates pain quality, sensory symptoms, pain pattern, and radiation of pain. Total scores range from -1 to 38, with higher scores indicating a greater likelihood and severity of neuropathic pain. Scale Information: painDETECT Questionnaire (PD-Q) Minimum Value: 1 Maximum Value: 38 Interpretation: Higher scores indicate more pronounced neuropathic pain characteristics and a greater likelihood of neuropathic pain. Clinical Interpretation: ≤12 = Neuropathic pain unlikely 13-18 = Ambiguous result ≥19 = Neuropathic pain likely
Residual Limb Pain Intensity
Residual limb pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average residual limb pain during the previous 7 days on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Scale Information: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate greater residual limb pain intensity and worse clinical outcomes.
Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time
Prosthesis tolerance will be assessed by measuring the average daily duration of prosthesis use reported by the participant. Prosthesis wearing time reflects the participant's ability to comfortably use the prosthesis during daily activities and rehabilitation. Measurement: Average daily prosthesis wearing time Unit of Measure: Hours per day (hours/day) Minimum Value: 0 hours/day Maximum Value: 24 hours/day Interpretation: Higher values indicate better prosthesis tolerance and greater successful adaptation to prosthetic use.
Analgesic Consumption Assessed as Oral Morphine Equivalent Daily Dose (OMEDD)
Analgesic consumption will be assessed by calculating the total daily opioid use and converting all opioid medications into Oral Morphine Equivalent Daily Dose (OMEDD) using established conversion factors. The average daily opioid requirement will be recorded throughout the study period. Measurement: Oral Morphine Equivalent Daily Dose (OMEDD) Unit of Measure: Milligrams per day (mg/day) Minimum Value: 0 mg/day Maximum Value: No predefined maximum value Interpretation: Higher values indicate greater analgesic requirements and potentially more severe pain.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
