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NCT Number: NCT07624890

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

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.

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Key information

Conditions

Neuroma Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Phantom Limb Pain After Amputation Platelet-rich Plasma (PRP) Stump Pain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feofaniya Clinical Hospital, Kyiv, Ukraine

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Lidocaine, Bupivacaine

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmytro Dmytriiev, PhD.Professor

CONTACT

[email protected]

+380674309449

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Other

Registry information

Official study title

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

Acronym: PRP-NEUROMA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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