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

2026년 5월 30일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 우크라이나
      • Kyiv, 우크라이나, 03143
        • Feofaniya Clinical Hospital
        • 연락하다:
          • Andrii Khomenko, MD
          • 전화번호: +380937635858
          • 이메일: farmen@ukr.net
      • Vinnytsia, 우크라이나, 21000
        • Vinnitsya university hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: 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.
활성 비교기: 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.
의약품: 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.
다른 이름들:
  • 부분 마취
  • 부피바카인

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Analgesic Consumption Assessed as Oral Morphine Equivalent Daily Dose (OMEDD)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ukrainian Society of Regional Anesthesia and Pain Therapy

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 15일

기본 완료 (추정된)

2026년 12월 15일

연구 완료 (추정된)

2026년 12월 15일

연구 등록 날짜

최초 제출

2026년 5월 23일

QC 기준을 충족하는 최초 제출

2026년 5월 30일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 30일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 07v21052026
  • USRA (기타 식별자: Ukranian Society of Regional Anesthesia and Pain Therapy)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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