Neuroma, Phantom Limb Pain After Amputation, Stump Pain, Platelet-rich Plasma (PRP)
Conditions
Keywords
Chronic Neuroma Pain, Residual Limb Pain, Combat-Related Amputation, Post-Amputation Pain Syndrome, Painful Stump Neuroma, Platelet-rich plasma
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.
Detailed description
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.
Interventions
BIOLOGICALPlatelet-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.
Ultrasound-guided perineuroma local anesthetic injection performed around the ultrasound-confirmed painful neuroma for treatment of chronic neuroma pain after combat-related amputation.
Sponsors
Ukrainian Society of Regional Anesthesia and Pain Therapy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Neuroma Pain Intensity Assessed Using the Numeric Rating Scale (NRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q) | 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 |
| Residual Limb Pain Intensity | 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. |
| Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time | 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. |
Countries
Ukraine
Contacts
CONTACTDmytro Dmytriiev, PhD.Professor
Outcome results
None listed