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

NCT07624890 | Not Yet Recruiting DMC

• 2 other identifiers: 07v21052026USRA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neuroma; Stump Pain; Platelet-rich Plasma (PRP); Phantom Limb Pain After Amputation

Keywords

Chronic Neuroma Pain; Residual Limb Pain; Combat-Related Amputation; Post-Amputation Pain Syndrome; Painful Stump Neuroma; Platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS)

  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 Outcomes (3)

• Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)

  Baseline to 12 and 24 weeks

• Residual Limb Pain Intensity

  Baseline to 12 and 24 weeks

• Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time

  Baseline to 12 and 24 weeks

Other Outcomes (1)

• Analgesic Consumption Assessed as Oral Morphine Equivalent Daily Dose (OMEDD)

  Baseline to 24 weeks

Study Arms (2)

PRP Injection Around Neuroma

EXPERIMENTAL

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

Local Anesthetic Injection

ACTIVE COMPARATOR

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

Interventions

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.

PRP Injection Around Neuroma

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.

Also known as: Lidocaine, Bupivacaine

Local Anesthetic Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (2)

Feofaniya Clinical Hospital

Kyiv, 03143, Ukraine

Location

Vinnitsya university hospital

Vinnytsia, 21000, Ukraine

Location

Related Publications (1)

• Yu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011 Apr;121(4):176-80. doi: 10.3109/00207454.2010.544432. Epub 2011 Jan 19.

  PMID: 21244302 RESULT

MeSH Terms

Conditions

Neuroma

Interventions

Injections; Anesthetics, Local; Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; mddmytriiev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and statisticians analyzing study data will remain blinded to treatment allocation whenever feasible. Treating clinicians performing ultrasound-guided injections will not be blinded because of differences in PRP preparation and injection procedures. Participants will be informed that they may receive one of two ultrasound-guided injection treatments for chronic neuroma pain.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.
• 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.

Locations

UA (2)