Ultrasound-Guided Platelet-Rich Plasma Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation (PRP-NEUROMA)

May 30, 2026 updated by: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

Ultrasound-Guided Platelet-Rich Plasma Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ukraine
      • Kyiv, Ukraine, 03143
        • Feofaniya Clinical Hospital
        • Contact:
          • Andrii Khomenko, MD
          • Phone Number: +380937635858
          • Email: farmen@ukr.net
      • Vinnytsia, Ukraine, 21000
        • Vinnitsya university hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Combat-related limb amputation
  • Chronic neuroma pain lasting ≥3 months
  • Ultrasound-confirmed painful neuroma
  • Average neuroma pain intensity ≥4/10 on the Numeric Rating Scale
  • Persistent pain interfering with rehabilitation, prosthesis use, or daily activities
  • Ability to undergo ultrasound-guided injection
  • Stable analgesic regimen for at least 14 days before enrollment
  • Ability to provide written informed consent

Exclusion Criteria:

  • 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
  • Severe coagulopathy or platelet disorder
  • Anticoagulant therapy contraindicating injection
  • Active malignancy
  • Severe uncontrolled systemic disease
  • Known allergy to local anesthetics
  • Inability to complete follow-up assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP Injection Around Neuroma
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 platelet-rich plasma injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Active Comparator: Local Anesthetic Injection
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 local anesthetic injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Other Names:
  • Lidocaine
  • Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Time Frame: Baseline to 12 weeks after injection

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
Time Frame: Baseline to 12 and 24 weeks

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
Baseline to 12 and 24 weeks
Residual Limb Pain Intensity
Time Frame: Baseline to 12 and 24 weeks

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
Time Frame: Baseline to 12 and 24 weeks

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Consumption Assessed as Oral Morphine Equivalent Daily Dose (OMEDD)
Time Frame: Baseline to 24 weeks

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.
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

May 23, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07v21052026
  • USRA (Other Identifier: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months after publication of the primary study results and ending 5 years after publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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