An interventional study of Botulinum Toxin Type A (BoNT-A) and Local Anesthetic Solution in Chronic Pain Due to Injury, Neuroma of Lower Limb and Neural Injury, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Completed at 2 sites in Ukraine. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Not applicable, Interventional, and Treatment
Patients with combat-related amputations frequently experience persistent neuroma pain that may interfere with rehabilitation, prosthesis use, sleep, mobility, and quality of life. Current treatment options often provide only temporary relief. This study aims to compare two ultrasound-guided injection approaches for chronic neuroma pain after combat-related amputation: botulinum toxin type A and local anesthetic injection.
Participants will be randomly assigned to receive one of the two treatments. Pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes will be evaluated during follow-up visits over a 24-week period.
The goal of the study is to determine whether botulinum toxin type A provides longer-lasting pain reduction and improved functional recovery compared with local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.
Neuroma pain is a common and disabling complication after combat-related limb 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.
Botulinum toxin type A has emerged as a potential treatment option because of its ability to modulate peripheral nociceptive signaling, reduce neurogenic inflammation, and decrease peripheral sensitization. However, evidence regarding its efficacy in patients with combat-related amputations remains limited.
The NEUROQUIET Trial is a multicenter, randomized, double-blind clinical trial designed to compare ultrasound-guided botulinum toxin type A injection versus ultrasound-guided local anesthetic injection for persistent neuroma pain after combat-related amputation.
Eligible participants with ultrasound-confirmed painful neuroma will be randomized in a 1:1 ratio to receive either botulinum toxin type A or local anesthetic injection under ultrasound guidance. Participants, outcome assessors, and data analysts will remain blinded to treatment allocation.
Patients will undergo longitudinal follow-up for 24 weeks. Outcomes will include pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, sleep disturbance, and patient-reported global improvement.
The study aims to determine whether botulinum toxin type A provides greater and longer-lasting analgesia compared with local anesthetic injection in patients with chronic neuroma pain following combat-related amputation.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 100 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound-guided perineuroma injection of botulinum toxin type A for persistent neuroma pain after combat-related amputation.
Drug: Botulinum Toxin Type A (BoNT-A)
Ultrasound-guided perineuroma injection of local anesthetic for persistent neuroma pain after combat-related amputation.
Drug: Local Anesthetic Solution
Ultrasound-guided perineuroma injection of botulinum toxin type A for treatment of persistent neuroma pain after combat-related amputation.
Ultrasound-guided perineuroma injection of local anesthetic for treatment of persistent neuroma pain after combat-related amputation.
Change in neuroma pain intensity measured
Assessment of change in average neuroma pain intensity using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) following ultrasound-guided injection treatment.
Time frame: Baseline to 12 weeks after intervention
Residual Limb Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
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." Higher scores indicate greater pain intensity and a worse clinical outcome. Scale Information: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate worse residual limb pain intensity.
Time frame: Baseline to 24 weeks
Pain Catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a validated 13-item self-report questionnaire designed to measure catastrophic thinking related to pain. The PCS evaluates three domains: rumination, magnification, and helplessness. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing and a worse psychological pain profile. Scale Information: Pain Catastrophizing Scale (PCS) Minimum Value: 0 Maximum Value: 52 Interpretation: Higher scores indicate greater pain catastrophizing and worse pain-related psychological outcomes.
Time frame: Baseline, 3 months, 6 months, and 12 months after amputation.
Prosthesis Tolerance Assessed Using the Prosthesis Evaluation Questionnaire (PEQ) - Utility and Satisfaction Domains
Prosthesis tolerance will be assessed using selected domains of the Prosthesis Evaluation Questionnaire (PEQ), a validated instrument evaluating comfort, utility, satisfaction, and functional use of the prosthesis. Scores range from 0 to 100, with higher scores indicating better prosthesis tolerance and satisfaction. Scale Information: Prosthesis Evaluation Questionnaire (PEQ) Minimum Value: 0 Maximum Value: 100 Interpretation: Higher scores indicate better prosthesis tolerance, comfort, and prosthetic adaptation.
Time frame: Baseline to 24 weeks
Analgesic Consumption
Analgesic consumption will be assessed by calculating the total daily analgesic use and converting opioid medications into Oral Morphine Equivalent Daily Dose (OMEDD). Non-opioid analgesics (e.g., acetaminophen, NSAIDs, gabapentinoids) will also be recorded. Higher opioid consumption indicates greater analgesic requirements and potentially more severe pain. Measurement: Oral Morphine Equivalent Daily Dose (OMEDD), expressed in milligrams per day (mg/day) Minimum Value: 0 mg/day Maximum Value: No predefined maximum value Interpretation: Higher values indicate greater analgesic consumption and higher pain management requirements.
Time frame: Baseline to 24 weeks
Patient Global Impression of Change (PGIC)
Overall perceived improvement will be assessed using the Patient Global Impression of Change (PGIC) scale. The PGIC is a validated patient-reported outcome measure that evaluates a participant's perception of change in pain, function, and overall health status since the beginning of treatment. Participants rate their overall improvement on a 7-point scale ranging from "Very much worse" to "Very much improved." Scale Information: Patient Global Impression of Change (PGIC) Minimum Value: 1 (Very much worse) Maximum Value: 7 (Very much improved) Interpretation: Higher scores indicate greater perceived improvement and better overall clinical outcomes. Scale Categories: 1. = Very much worse 2. = Much worse 3. = Minimally worse 4. = No change 5. = Minimally improved 6. = Much improved 7. = Very much improved
Time frame: Week 12 and Week 24
Adverse Events
Adverse events will be assessed by recording the occurrence, type, severity, and relationship to treatment throughout the study period. Events may include medication-related adverse effects, prosthesis-related complications, falls, skin breakdown, residual limb complications, infections, hospitalizations, and other clinically significant events. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, when applicable. Measurement: Number of participants experiencing one or more adverse events. Minimum Value: 0 participants Maximum Value: Number of participants enrolled in the study Interpretation: Higher values indicate a greater incidence of adverse events and worse safety outcomes. Additional Safety Assessment: Severity of adverse events will be categorized as Grade 1 (Mild) to Grade 5 (Death related to adverse event) according to CTCAE v5.0.
Time frame: Baseline to 24 weeks
Sleep Disturbance
Sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item questionnaire that evaluates subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction during the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality and greater sleep disturbance. Scale Information: Pittsburgh Sleep Quality Index (PSQI) Minimum Value: 0 Maximum Value: 21 Interpretation: Higher scores indicate worse sleep quality and greater sleep disturbance. Clinical Interpretation: A global PSQI score \>5 is commonly considered indicative of clinically significant sleep disturbance.
Time frame: Baseline to 24 weeks
Functional Mobility
Functional mobility will be assessed using the Amputee Mobility Predictor (AMP), a validated performance-based instrument designed to evaluate ambulatory potential, balance, transfers, gait, and functional mobility in individuals with lower-limb amputation. The scale assesses the patient's ability to perform a series of mobility tasks and predicts prosthetic functional potential. Scale Information: Amputee Mobility Predictor (AMP) Minimum Value: 0 Maximum Value: 47 Interpretation: Higher scores indicate better functional mobility, greater ambulatory capacity, and improved rehabilitation outcomes. Clinical Interpretation: Higher AMP scores are associated with higher functional levels and greater potential for successful prosthetic use.
Time frame: Baseline to 24 weeks
Need for Repeat Intervention
he need for repeat intervention will be assessed by recording the number of participants who require additional pain-related interventions following the initial treatment. Repeat interventions may include repeat nerve blocks, cryoneurolysis, radiofrequency ablation, neuroma surgery, revision procedures, additional injections, or other clinically indicated pain-management procedures. Measurement: Number of participants requiring one or more additional pain-related interventions during follow-up. Minimum Value: 0 participants Maximum Value: Number of participants enrolled in the study Interpretation: Higher values indicate a greater need for additional interventions and may reflect reduced durability or effectiveness of the initial treatment. Additional Analysis: Time to first repeat intervention (days) may also be recorded and analyzed as a secondary outcome.
Time frame: Up to 24 weeks
Patient Satisfaction
Patient satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-8), a validated 8-item patient-reported outcome measure evaluating satisfaction with treatment, services received, and overall care experience. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with treatment outcomes and care. Scale Information: Client Satisfaction Questionnaire (CSQ-8) Minimum Value: 8 Maximum Value: 32 Interpretation: Higher scores indicate greater patient satisfaction and better perceived treatment outcomes.
Time frame: Week 12 and Week 24
Neuroma Maximum Diameter Measured by High-Resolution Ultrasound
Neuroma size will be assessed using high-resolution ultrasound. The maximum neuroma diameter will be measured in the longitudinal or transverse plane and recorded in millimeters (mm). The largest measured diameter will be used for analysis. Unit of Measure: Millimeters (mm) Minimum Value: 0 mm Maximum Value: No predefined maximum value Interpretation: Higher values indicate larger neuroma size and greater structural abnormality.
Time frame: Baseline and Week 24
Plan to share: Yes — De-identified individual participant data including demographic characteristics, pain intensity scores, neuropathic pain assessments, phantom limb pain measures, prosthesis tolerance outcomes, adverse events, and follow-up assessments collected during the study will be available for sharing. The study protocol and statistical analysis plan may also be shared upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
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 documents will be available to qualified researchers upon reasonable request to the study investigators. Requests will be reviewed for scientific validity and compliance with institutional and ethical requirements.
Data sharing details ↗ · www.uaratb.org
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Studies of the drug tested here: Botulinum toxin type A
Ukrainian Society of Regional Anesthesia and Pain Therapy