An interventional study of Botulinum toxin type A injection in Chronic Pain, Neuroma and Botulinium Toxin-A, 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 2026-10-06.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Not applicable, Interventional, and Treatment
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
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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 direct intraneuroma injection of botulinum toxin type A for treatment of chronic neuroma pain after combat-related amputation.
Drug: Botulinum toxin type A injection
Ultrasound-guided perineuroma injection of botulinum toxin type A surrounding the neuroma for treatment of chronic neuroma pain after combat-related amputation.
Drug: 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.
Also known as: Ultrasound-Guided Botulinum Toxin Injection
Change in chronic neuroma pain intensity
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.
Time frame: Baseline to 12 weeks after injection
Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
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
Time frame: Baseline to 12 and 24 weeks
Residual Limb Pain Intensity
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.
Time frame: Baseline to 12 and 24 weeks
Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time
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.
Time frame: Baseline, 3 months, 6 months, and 12 months after amputation or intervention.
Plan to share: Yes — 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.
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.
Data sharing details ↗ · uaratb.org
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Studies of the drug tested here: Botulinum toxin type A
Ukrainian Society of Regional Anesthesia and Pain Therapy