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| ID | Type | Description | Link |
|---|---|---|---|
| USRA | Other Identifier | Ukranian Society of Regional Anesthesia and Pain Therapy |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Injection Around Neuroma | Experimental | 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. |
|
| Local Anesthetic Injection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) Injections | Biological | Ultrasound-guided perineuroma platelet-rich plasma injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks after injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmytro Dmytriiev, PhD.Professor | Contact | +380674309449 | mddmytriiev@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feofaniya Clinical Hospital | Kyiv | 03143 | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21244302 | Result | Yu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011 Apr;121(4):176-80. doi: 10.3109/00207454.2010.544432. Epub 2011 Jan 19. |
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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.
Beginning 6 months after publication of the primary study results and ending 5 years after publication.
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.
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Outcome assessors and statisticians analyzing study data will remain blinded to treatment allocation whenever feasible. Treating clinicians performing ultrasound-guided injections will not be blinded because of differences in PRP preparation and injection procedures. Participants will be informed that they may receive one of two ultrasound-guided injection treatments for chronic neuroma pain.
| Local Anesthetic Injection | Drug | Ultrasound-guided perineuroma local anesthetic injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation. |
|
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| 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. | 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. | Baseline to 12 and 24 weeks |
| Baseline to 24 weeks |
| Vinnitsya university hospital | Vinnytsia | 21000 | Ukraine |
|
| ID | Term |
|---|---|
| D009463 | Neuroma |
| ID | Term |
|---|---|
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D000779 | Anesthetics, Local |
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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