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

This is an interventional treatment trial for Neuropathic Pain focused on measuring transcutaneous magnetic stimulation, axon therapy, post-traumatic peripheral neuropathic pain Read More

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.
2. Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, and other study procedures subject is able and willing to complete twice daily diary.
3. Subject must be literate in English to fill out the study questionnaires.
4. Men or women of any race or ethnicity who are 18-75 years of age.
5. Subject must have chronic peripheral neuropathic pain present for more than three months after a traumatic or surgical event per medical history (this may include, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns, or crush injury).
6. Subject has a score ≥6 on VAS at Enrollment/Screening Visit.
7. Subject has completed at least one of the two daily pain diary entries on at least three days between the Enrollment/Screening Visit and Randomization Visit (Visit 1) with a mean pain score of ≥4 and ≤10 based on Daily VAS to be eligible for randomization.
8. Subject has been on a stable pain medication regimen for at least 28 days or is not taking pain medications, as determined by the investigator, at the baseline assessment in this study.
9. Subject must have their implicated peripheral nerve(s) identified and documented in their medical record.

Exclusion Criteria

1. Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia, or carpal tunnel syndrome; subjects whose post- traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
2. Subject has a currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).
3. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
4. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
5. Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study.
6. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.
7. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate to participate in the study.
8. Subjects with pending Worker's Compensation, Worker's Compensation, civil litigation, or disability claims pertinent to the subject based upon trauma; current involvement in out-of-court settlements for claims pertinent to subject's trauma; Subjects with fully resolved litigation and compensation claims can participate.
9. Subjects who have had a diagnosis of malignancy other than basal cell carcinoma, or carcinoma in situ of the cervix within the past five years, to include life expectancy less than 1 year due to advanced malignancy.
10. Subjects with implantable "electrical" medical devices such as a cardiac pacemaker, defibrillator, or insulin pump within four (4) inches or less of the site of pain to be treated by Axon Therapy. (Subject with an implantable device greater than four (4) inches from the site of pain to be treated should NOT be excluded).
11. Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
12. Subjects who have failed other neuromodulation implantable device for the same indication
13. Subjects with shrapnel or ferromagnetic objects
14. Subject is currently taking a morphine equivalent daily dose > 120 mg/day.
15. Subject is a woman of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.