An interventional study of Platelet-Rich Plasma (PRP) Injections and Local Anesthetic Injection in Neuroma, Phantom Limb Pain After Amputation and Stump Pain, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Completed at 2 sites in Ukraine. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Not applicable, Interventional, and Treatment
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.
Chronic neuroma pain is a frequent and disabling complication following combat-related limb trauma and amputation. Persistent neuroma pain may contribute to residual limb pain, phantom limb pain, impaired prosthesis tolerance, sleep disturbance, reduced mobility, and decreased quality of life. Conventional treatment strategies, including local anesthetic injections, often provide only temporary pain relief and limited long-term functional improvement.
Platelet-rich plasma (PRP) has emerged as a potential regenerative treatment option because of its possible effects on tissue repair, neuroinflammation, peripheral sensitization, and scar-related nerve irritation. PRP contains multiple growth factors and bioactive molecules that may support peripheral nerve healing and modulation of chronic neuropathic pain mechanisms. However, evidence regarding PRP treatment for chronic neuroma pain after combat-related amputation remains limited.
This prospective multicenter controlled study is designed 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.
Patients with ultrasound-confirmed painful neuromas will undergo ultrasound-guided perineuroma injection using either PRP or local anesthetic according to the study protocol. All procedures will be performed under sterile conditions by clinicians experienced in ultrasound-guided pain interventions.
Clinical follow-up will include assessment of neuroma pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, patient-reported improvement, and adverse events.
The study aims to evaluate the safety, feasibility, and potential clinical effectiveness of PRP injection as a regenerative treatment strategy for chronic neuroma pain following combat-related amputation.
55 studies on the registry are indexed under Neuroma; 10 are open to participants now.
This study's enrollment of 100 is above the median of 34 across 36 interventional studies indexed under Neuroma.
Browse Neuroma studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound-guided perineuroma platelet-rich plasma (PRP) injection performed for treatment of chronic neuroma pain after combat-related amputation. PRP will be prepared using autologous blood and injected under sterile conditions around the ultrasound-confirmed painful neuroma.
Biological: Platelet-Rich Plasma (PRP) Injections
Ultrasound-guided perineuroma local anesthetic injection performed for treatment of chronic neuroma pain after combat-related amputation under sterile conditions around the ultrasound-confirmed painful neuroma.
Drug: Local Anesthetic Injection
Ultrasound-guided perineuroma platelet-rich plasma injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Ultrasound-guided perineuroma local anesthetic injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Also known as: Lidocaine, Bupivacaine
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.
Time frame: Baseline to 12 weeks after injection
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
Time frame: Baseline to 12 and 24 weeks
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.
Time frame: Baseline to 12 and 24 weeks
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.
Time frame: Baseline to 12 and 24 weeks
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.
Time frame: Baseline to 24 weeks
Plan to share: Yes — De-identified individual participant data including demographic characteristics, ultrasound findings, chronic neuroma pain intensity scores, neuropathic pain assessments, phantom limb pain measures, residual limb pain outcomes, prosthesis tolerance assessments, analgesic consumption, adverse events, and follow-up clinical evaluations collected during the study will be available for sharing. The study protocol, statistical analysis plan, and analytic code may also be shared upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.
Access criteria: De-identified individual participant data and supporting study documents will be available to qualified researchers, clinicians, and academic institutions upon reasonable request to the study investigators. Shared materials may include demographic data, ultrasound findings, pain assessments, follow-up outcomes, study protocol, statistical analysis plan, and analytic code. Requests will be reviewed for scientific validity, ethical compliance, and data protection considerations. Data access will be provided through secure institutional communication and data-sharing agreements when applicable.
Data sharing details ↗ · uaratb.org
Ran from Sep 2026 to primary completion in Sep 2026, 0 months.
Of 21 interventional studies with no phase under Neuroma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 48. This study's 0 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: start Dec 2026 → Sep 2026, primary completion Dec 2026 → Sep 2026 and completion Dec 2026 → Sep 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Platelet rich plasma
Ukrainian Society of Regional Anesthesia and Pain Therapy