Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation (IN-PERI NEUROM)

30 mei 2026 bijgewerkt door: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Study

Patients with combat-related amputations frequently experience chronic neuroma pain that may interfere with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a potential treatment option for persistent neuroma pain; however, the optimal injection technique remains unclear.

This prospective multicenter study aims to compare two ultrasound-guided botulinum toxin injection techniques for chronic neuroma pain after combat-related amputation: intraneuroma injection and perineuroma injection.

Participants with ultrasound-confirmed painful neuromas will undergo one of the two injection approaches based on the treating physician's clinical decision and local practice. Pain intensity, neuropathic pain characteristics, phantom limb pain, prosthesis tolerance, functional outcomes, and adverse events will be evaluated during follow-up.

The goal of the study is to evaluate the feasibility, safety, and potential clinical effectiveness of intraneuroma and perineuroma botulinum toxin type A injection techniques in patients with chronic neuroma pain following combat-related amputation.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Chronic neuroma pain is a common 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, reduced mobility, sleep disturbance, and decreased quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a promising treatment option because of its potential effects on peripheral nociceptive signaling, neurogenic inflammation, and neuropathic pain modulation.

However, the optimal injection technique for botulinum toxin administration in painful neuromas remains unclear. Two commonly used approaches include direct intraneuroma injection and perineuroma injection surrounding the neuroma. Intraneuroma injection may provide more direct pharmacological modulation of pathological nerve tissue, whereas perineuroma injection may reduce the risk of mechanical nerve injury while still targeting peripheral sensitization mechanisms.

This prospective multicenter study is designed to evaluate the feasibility, safety, and clinical outcomes associated with intraneuroma and perineuroma ultrasound-guided botulinum toxin type A injection techniques in patients with chronic neuroma pain after combat-related amputation.

Patients with ultrasound-confirmed painful neuromas will undergo ultrasound-guided botulinum toxin type A injection using one of the two injection techniques according to local clinical practice and physician decision-making. 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 improve understanding of ultrasound-guided botulinum toxin injection strategies for chronic neuroma pain and to identify potential differences in safety and clinical effectiveness between intraneuroma and perineuroma approaches in patients with combat-related amputations.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Oekraïne
      • Kyiv, Oekraïne, 03143
        • Feofaniya Clinical Hospital
        • Contact:
          • Andrii Khomenko, MD
          • Telefoonnummer: +380937635858
          • E-mail: farmen@ukr.net
    • Вінницька
      • Vinnytsia, Вінницька, Oekraïne, 21000
        • Vinnitsya university hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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
  • 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 botulinum toxin injection for neuroma pain within 6 months
  • Previous neuroma surgery within 3 months
  • Known allergy to botulinum toxin type A
  • Coagulopathy or anticoagulation contraindicating injection
  • Severe uncontrolled systemic disease
  • Inability to complete follow-up assessments

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intraneuroma Botulinum Toxin Type A Injection
Ultrasound-guided direct intraneuroma injection of botulinum toxin type A for treatment of chronic neuroma pain after combat-related amputation.
Geneesmiddel: Botulinum toxin type A injection
Ultrasound-guided botulinum toxin type A injection performed for treatment of chronic neuroma pain after combat-related amputation. Two injection techniques will be evaluated: direct intraneuroma injection and perineuroma injection surrounding the neuroma. Procedures will be performed under sterile conditions using high-frequency musculoskeletal ultrasound guidance by clinicians experienced in ultrasound-guided pain interventions.
Andere namen:
  • Ultrasound-Guided Botulinum Toxin Injection
Experimenteel: Perineuroma Botulinum Toxin Injection
Ultrasound-guided perineuroma injection of botulinum toxin type A surrounding the neuroma for treatment of chronic neuroma pain after combat-related amputation.
Geneesmiddel: Botulinum toxin type A injection
Ultrasound-guided botulinum toxin type A injection performed for treatment of chronic neuroma pain after combat-related amputation. Two injection techniques will be evaluated: direct intraneuroma injection and perineuroma injection surrounding the neuroma. Procedures will be performed under sterile conditions using high-frequency musculoskeletal ultrasound guidance by clinicians experienced in ultrasound-guided pain interventions.
Andere namen:
  • Ultrasound-Guided Botulinum Toxin Injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in chronic neuroma pain intensity
Tijdsspanne: Baseline to 12 weeks after injection

Change in 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." The change from baseline NRS score will be calculated at each follow-up assessment.

Scale Information:

Numeric Rating Scale (NRS)

Minimum Value:

0

Maximum Value:

10 Interpretation: Higher scores indicate greater chronic neuroma pain intensity and worse clinical outcomes. Negative change from baseline indicates improvement.
Baseline to 12 weeks after injection

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
Tijdsspanne: Baseline to 12 and 24 weeks

Neuropathic pain characteristics will be assessed using the painDETECT Questionnaire (PD-Q), a validated self-administered questionnaire designed to identify and quantify neuropathic pain symptoms. The questionnaire evaluates sensory descriptors, pain course pattern, and pain radiation. Total scores range from -1 to 38.

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 = Uncertain neuropathic pain component

≥19 = Neuropathic pain likely
Baseline to 12 and 24 weeks
Residual Limb Pain Intensity
Tijdsspanne: 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 ("no pain") to 10 ("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 pain outcomes.
Baseline to 12 and 24 weeks
Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time
Tijdsspanne: Baseline, 3 months, 6 months, and 12 months after amputation or intervention.

Prosthesis tolerance will be assessed by measuring the average daily duration of prosthesis use reported by the participant. Average daily prosthesis wearing time will be recorded as the total number of hours the prosthesis is worn during a typical day.

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, greater comfort during use, and improved adaptation to the prosthesis.
Baseline, 3 months, 6 months, and 12 months after amputation or intervention.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Onderzoekers

  • Hoofdonderzoeker: Andrii Khomenko, MD, Feofaniya Clinical Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

27 mei 2026

Primaire voltooiing (Geschat)

27 mei 2026

Studie voltooiing (Geschat)

15 december 2026

Studieregistratiedata

Eerst ingediend

23 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

30 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 092026v25052026
  • USRA (Andere identificatie: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data including demographic characteristics, ultrasound findings, neuroma pain intensity scores, neuropathic pain assessments, phantom limb pain measures, residual limb pain outcomes, prosthesis tolerance assessments, adverse events, and follow-up clinical evaluations collected during the study will be available for sharing. The study protocol and statistical analysis plan may also be shared upon reasonable request.

IPD-tijdsbestek voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren