Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).
This is a two-phase study. Phase 1 is a double blinded, two-arm, randomized, multi-center clinical trial to assess 1-month efficacy as compared to a sham group. Up to approximately 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups: 1. Axon Therapy plus CMM (AT+CMM) 2. Sham plus CMM (Sham+CMM) Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study. Phase 2 of the study is an unblinded, one-arm, multi-center trial to assess extended efficacy of the treatment. At Day 30, subjects will be unblinded and allowed to remain in the study for an additional 60 (AT+CMM) to 90 (ATx+CMM) days. Those in the Sham arm can choose to crossover to active treatment ( ATx+CMM). Subjects in the AT+CMM arm will return to the clinic as follows: * Month 2: Bi-weekly treatment * Month 3: Treatments every 2-4 weeks * Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6. Subjects in the ATx+CMM arm will return to the clinic as follows: * Month 2: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments * Month 3: Bi-weekly treatment * Month 4: Treatments every 2-4 weeks * Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6. Subjects who do not choose to remain in the study will be monitored for 30 days for AEs and then they will exit the study. The subject's reason for exiting the study will be recorded. In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through Day 30 of the study (Day 60 for ATx+CMM subjects). Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events. Weekly phone follow-up will occur only during weeks when the subject is not seen in the clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
93
transcutaneous magnetic stimulation (TMS)
Sham and CMM
Florida Pain Management Associates, P.A.
Sebastian, Florida, United States
Truwell Health
St. Petersburg, Florida, United States
Florida Pain Management Associates, P.A.
Vero Beach, Florida, United States
Centurion Spine and Pain Centers
Brunswick, Georgia, United States
Comparison of the Proportion of Responders
The primary efficacy endpoint is a between groups comparison of pain change from baseline to 30 days.
Time frame: 30 days
Comparison of therapy-related AEs between the 2 Study arms
The primary safety endpoint for this study is a comparison of therapy-related AEs through Day 30 between the 2 arms of the Study.
Time frame: 30 days
Visual Analog Scale (VAS) for Pain
Scores from daily diaries will be compared to baseline overall and by group (Axon therapy (AT) plus CMM and AT crossover (ATx) plus CMM)
Time frame: 30- and 90-days post-treatment
VAS for Numbness
Scores from daily diaries will be compared to baseline overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
Brief Pain Inventory (BPI)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
Daily Sleep Interference Scale (DSIS)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
EQ-5D-3L
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
Patient Global Impression of Change (PGIC)
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Centurion Spine and Pain Centers
Waycross, Georgia, United States
Carolinas Pain Institute and Center for Clinical Research
Winston-Salem, North Carolina, United States
SC Pain and Spine Specialists, LLC
Murrells Inlet, South Carolina, United States
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Time frame: 30- and 90-days post-treatment
Depression Anxiety Stress Scales (DASS)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
Pain Disability Index (PDI)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Time frame: 30- and 90-days post-treatment
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) Questionnaire
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
In-clinic VAS Pain Scores
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
Increase from baseline pain medication within four weeks of the Day 90 visit (based on prescribed doses)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time frame: 30- and 90-days post-treatment
Proportion of subjects who discontinue treatment
Proportion of subjects who discontinue treatment will be compared between groups
Time frame: 30- and 90-days post-treatment
Neurological Exam - percentage of treatment arm with a change in neurological status
Percentage of treatment arm (including crossover subjects) with a change in neurological status as determined by neurological exam on Day 90 after start of active treatment.
Time frame: 90 days post-treatment