Chronic Pain Due to InjuryNEUROQUIETNCT07626983
Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation
A study testing Botulinum Toxin Type A (BoNT-A) and Local Anesthetic Solution in people with Chronic Pain Due to Injury and Neuroma of Lower Limb, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 2 sites in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain Due to Injury, Neuroma of Lower Limb, Neural Injury
- What is being tested?
- Botulinum Toxin Type A (BoNT-A) and Local Anesthetic Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUkraine
- Study dates
- 30 May 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years
- Combat-related limb amputation
- Persistent neuroma pain lasting ≥3 months
- Ultrasound-confirmed neuroma
- Positive Tinel sign over the neuroma
- Average pain intensity ≥4/10 on the Numeric Rating Scale (NRS)
- Stable analgesic regimen for at least 14 days before enrollment
- Ability to provide written informed consent
Who cannot join
- Active infection at the injection site
- Previous botulinum toxin injection within 6 months
- Previous neuroma surgery within 3 months
- Severe uncontrolled psychiatric disorder
- Coagulopathy or anticoagulant therapy contraindicating injection
- Known allergy to botulinum toxin or local anesthetics
- Severe uncontrolled systemic disease
- Inability to complete study follow-up or questionnaires
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Feofaniya Clinical Hospital
Kyiv, Vinnytsia Oblast, 03143
Vinnitsya university hospital
Vinnitsa, 21000
About this study
Official title: Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Multicenter Randomized Double-Blind Trial
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.
Read the detailed description
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.
- Conditions
- Chronic Pain Due to Injury, Neuroma of Lower Limb, Neural Injury, Neuroma of Upper Limb, Combat Related Symptoms
- Being tested
- Botulinum Toxin Type A (BoNT-A), Local Anesthetic Solution
- Keywords
- Neuroma pain, Combat-related amputation, Botulinum toxin type A, Local anesthetic injection, Ultrasound-guided injection, Phantom limb pain, Residual limb pain, Neuropathic pain, Military trauma, Chronic post-amputation pain, Ultrasound-guided pain intervention
- Medical subject headings
- Phantom Limb, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A (BoNT-A)Drug
Ultrasound-guided perineuroma injection of botulinum toxin type A for treatment of persistent neuroma pain after combat-related amputation.
Local Anesthetic SolutionDrug
Ultrasound-guided perineuroma injection of local anesthetic for treatment of persistent neuroma pain after combat-related amputation.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Ultrasound-guided perineuroma injection of botulinum toxin type A for persistent neuroma pain after combat-related amputation. Receives: Drug: Botulinum Toxin Type A (BoNT-A) |
| Local Anesthetic | Active comparator | Ultrasound-guided perineuroma injection of local anesthetic for persistent neuroma pain after combat-related amputation. Receives: Drug: Local Anesthetic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks after intervention
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- = Very much worse
- = Much worse
- = Minimally worse
- = No change
- = Minimally improved
- = Much improved
- = Very much improved
Measured: 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.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 May 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain Due to InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided botulinum toxin type A injection or ultrasound-guided local anesthetic injection for persistent neuroma pain after combat-related amputation. The study will use a parallel-group design in which each participant receives only one assigned intervention throughout the study period. Participants, outcome assessors, and data analysts will remain blinded to treatment allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626983
- Sponsor's protocol ID
- 2205v0123052026
- Other IDs
- UARA-NEUROQUIET, UARA-NEUROQUIET
- Acronym
- NEUROQUIET
- Status last verified
- Oct 2026
- First submitted
- 23 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Climent JM, Mondejar-Gomez F, Rodriguez-Ruiz C, Diaz-Llopis I, Gomez-Gallego D, Martin-Medina P. Treatment of Morton neuroma with botulinum toxin A: a pilot study. Clin Drug Investig. 2013 Jul;33(7):497-503. doi: 10.1007/s40261-013-0090-0.
PubMed 23740337
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Multicenter Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07626983
- Acronym / sponsor ID
- NEUROQUIET / 2205v0123052026
- Conditions
- Chronic Pain Due to Injury, Neuroma of Lower Limb, Neural Injury, Neuroma of Upper Limb, Combat Related Symptoms
- Keywords
- Neuroma pain, Combat-related amputation, Botulinum toxin type A, Local anesthetic injection, Ultrasound-guided injection, Phantom limb pain, Residual limb pain, Neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided botulinum toxin type A injection or ultrasound-guided local anesthetic injection for persistent neuroma pain after combat-related amputation. The study will use a parallel-group design in which each participant receives only one assigned intervention throughout the study period. Participants, outcome assessors, and data analysts will remain blinded to treatment allocation.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Drug: Botulinum Toxin Type A (BoNT-A)Ultrasound-guided perineuroma injection of botulinum toxin type A for persistent neuroma pain after combat-related amputation. |
| Local Anesthetic | Active comparator | Drug: Local Anesthetic SolutionUltrasound-guided perineuroma injection of local anesthetic for persistent neuroma pain after combat-related amputation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Combat-related limb amputation
- Persistent neuroma pain lasting ≥3 months
- Ultrasound-confirmed neuroma
- Positive Tinel sign over the neuroma
Key exclusion criteria (8 listed)
- Active infection at the injection site
- Previous botulinum toxin injection within 6 months
- Previous neuroma surgery within 3 months
- Severe uncontrolled psychiatric disorder
- Coagulopathy or anticoagulant therapy contraindicating injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A (BoNT-A)Ultrasound-guided perineuroma injection of botulinum toxin type A for treatment of persistent neuroma pain after combat-related amputation. | Drug | Botulinum Toxin Type A |
| Local Anesthetic SolutionUltrasound-guided perineuroma injection of local anesthetic for treatment of persistent neuroma pain after combat-related amputation. | Drug | Local Anesthetic |
Primary outcome
Change in neuroma pain intensity measured
Time frame: Baseline to 12 weeks after intervention
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.
6 secondary outcomes
Residual Limb Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Time frame: Baseline to 24 weeks
Pain Catastrophizing
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
Time frame: Baseline to 24 weeks
Analgesic Consumption
Time frame: Baseline to 24 weeks
Patient Global Impression of Change (PGIC)
Time frame: Week 12 and Week 24
Adverse Events
Time frame: Baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 23740337Climent JM, Mondejar-Gomez F, Rodriguez-Ruiz C, Diaz-Llopis I, Gomez-Gallego D, Martin-Medina P. Treatment of Morton neuroma with botulinum toxin A: a pilot study. Clin Drug Investig. 2013 Jul;33(7):497-503. doi: 10.1007/s40261-013-0090-0.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A (BoNT-A) and Local Anesthetic Solution in people with Chronic Pain Due to Injury and Neuroma of Lower Limb, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuroma pain intensity measured (time frame: Baseline to 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.