Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain Compared to Conventional Medical Management

Summary

Participation Requirements

Description

This is a prospective, randomized, controlled, multi-center, clinical trial in which 128 participants diagnosed with PTPNP will be randomized 1:1 into one of two treatment groups: CMM plus Axon Therapy (n=64) CMM alone (n=64) Participants will be consented, screened, and undergo a 7-day baseline ass...

This is a prospective, randomized, controlled, multi-center, clinical trial in which 128 participants diagnosed with PTPNP will be randomized 1:1 into one of two treatment groups: CMM plus Axon Therapy (n=64) CMM alone (n=64) Participants will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Participants meeting inclusion criteria will undergo an in-clinic baseline evaluation, receive randomization assignment, and start their respective treatments. All participants will return to the clinic for assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 30 days) and Day 365 (± 30 days). Participants randomized to the CMM plus Axon Therapy group will return to the clinic for Axon Therapy treatments as follows: Month 1: 6 treatments WEEK 1: 3 treatments (consecutive treatments are best) WEEK 2-4: Weekly treatments Month 2: Bi-monthly treatment Months 3-12: Treatments every 2-4 weeks In addition to in-clinic assessments and treatments, all participants will a receive weekly phone follow-up to assess pain intensity and occurrence of adverse events after treatment starts. Weekly phone follow-ups will only occur during weeks when the participant is not in clinic for treatment.

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