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

30. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Ukraina
      • Kyiv, Ukraina, 03143
        • Feofaniya Clinical Hospital
        • Ta kontakt med:
          • Andrii Khomenko, MD
          • Telefonnummer: +380937635858
          • E-post: farmen@ukr.net
      • Vinnytsia, Ukraina, 21000
        • Vinnitsya university hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: 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.
Aktiv komparator: 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.
Legemiddel: 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.
Andre navn:
  • Lidokain
  • Bupivakain

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Analgesic Consumption Assessed as Oral Morphine Equivalent Daily Dose (OMEDD)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. desember 2026

Primær fullføring (Antatt)

15. desember 2026

Studiet fullført (Antatt)

15. desember 2026

Datoer for studieregistrering

Først innsendt

23. mai 2026

Først innsendt som oppfylte QC-kriteriene

30. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 07v21052026
  • USRA (Annen identifikator: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere