Compare Axon Therapy using transcutaneous magnetic stimulation (tMS) against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP).
Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation, receive randomization assignment, and start their respective treatments. Those randomized to the CMM plus Axon Therapy group will receive their first Axon Therapy treatment and then have a follow-up phone call after 24 hours to assess if the patient is a candidate for Axon Therapy, that is if the subject is neuropathic or nociceptive. Those that are not candidates for Axon Therapy will be monitored for 30 days for AEs and then they will exit the study as screen failures. Screen failures will not count against enrollment numbers. All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 14 days) and Day 365 (± 30 days) and if in 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-Weekly treatment * Months 3-12: Treatments every 2-4 weeks * Additional treatments to treat flare ups; defined as an episode of pain with a VAS \>greater or equal to 6 following an increase in daily activities. At day 90 (± 15 days), subjects will be allowed to crossover to the alternative treatment group. Subjects who crossover from CMM to CMM plus Axon Therapy will follow the CMM plus Axon Therapy regimen, remaining in the study for 15 months. These subjects will have follow-up visits at Day 120 (± 14 days), Day 180 (± 14 days) ,Day 270 (± 14 days), and Day 450 (± 30 days). Subjects who crossover from CMM plus Axon Therapy to CMM will be monitored for 30 days for AEs and then they will exit the study. The reason for ending therapy will be recorded. In addition to in-clinic assessments and treatments, all subjects will complete an electronic daily diary up to twice daily throughout the first 90 days and for crossover subjects they will complete 90 days of Axon treatment therapy and up to Day 180. They will 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 subject is not seen in the clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
transcutaneous magnetic stimulation (tMS)
National Spine and Pain Centers
Shrewsbury, New Jersey, United States
Carolinas Pain Institute
Winston-Salem, North Carolina, United States
SC Pain and Spine Specialists (Crescent Moon Research Corp)
Murrells Inlet, South Carolina, United States
Comparison of the Proportion of Responders
The primary effectiveness endpoint is a between groups comparison of the proportion of responders, defined as a subject who experiences 50% or greater reduction from baseline in neuropathic pain intensity as measured by in-clinic visual analog score (VAS) for primary area of pain at Day 90 with no increase in baseline pain medications within 4 weeks of the Day 90 visit.
Time frame: 90 days
Visual Analog Scale (VAS) for Pain
Scores from daily diaries at 30 and 90 days (analysis will include a comparison of compliance across treatment groups)
Time frame: 30 and 90 days
Brief Pain (BPI Inventory
The secondary endpoints of this trial are between group comparisons
Time frame: 90 days
Daily Sleep Interference Scale (DSIS)
The secondary endpoints of this trial are between group comparisons
Time frame: 30 and 90 days
5D-5D-3L
The secondary endpoints of this trial are between group comparisons
Time frame: 90 days
Patient Global Impression of Change (PGIC)
The secondary endpoints of this trial are between group comparisons
Time frame: 90 days
Depression Anxiety Stress Scales (DASS)
The secondary endpoints of this trial are between group comparisons b
Time frame: 90 days
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Pain Disability Index (PDI)
The secondary endpoints of this trial are between group comparisons
Time frame: 90 days