The goal of this clinical trial is to learn if adaptative transcutaneous magnetic stimulation (AtMS) works to reduce pain caused by post-traumatic peripheral neuropathic pain (PTP-NP) within Veterans and/or active duty military personnel. It will also learn about the safety of AtMS. The main questions it aims to answer are:
1. What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS? 2. What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS? 3. What are the effects of AtMS in improving mood in patients suffering from PTP NP compared FtMS and Sham-tMS?
Researchers will compare AtMS, FtMS and Sham-tMS to see if AtMS is the best form of tMS in treating PTP-NP.
Participants will undergo the following:
1. Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks. 2. Visit the clinic a total of 12 times for assessments, check ups, and treatments. 3. Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.
Veterans (men or women) of any race or ethnicity who are at least 18 years of age
Chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history
Have an average daily Numerical Pain Rating Scale (NPRS) score > 3
At least one negative or positive sensory sign or symptom confined to innervation territory of the lesioned nervous structure
Pregnancy
Subjects with central neuropathic pain (ex: due to diabetic peripheral neuropathy, HIV, chemo/anti-viral therapy, carpal tunnel syndrome, post-traumatic pain classified as central rather than peripheral)
Subjects with pain due to Complex Regional Pain Syndrome
Phantom limb pain after amputation (stump pain and phantom sensation are allowed)
Factorial
Transcutaneous magnetic stimulation (tMS)
DeviceActive tMS will be given at different PTP-NP sites with an active tMS coil.
Sham transcutaneous magnetic stimulation (Sham-tMS)
DeviceSham-tMS will be given at different PTP-NP sites with a sham tMS coil. All parameters of the treatment will appear identical to the active treatment.
Patient Machine Interface (PMI)
DeviceThe PMI will be used to help determine intensities for tMS treatments.
Neuropathic Pain Rating
0 is equivalent to no neuropathic pain and 10 indicates the worst possible neuropathic pain
Mood
Hamilton Rating Scale for Depression (HRSD) an interviewed asks 21 questions about mood, sleep, appetite, and other symptoms related to depression. The interviewer rates the severity of each symptom based on a pre-defined scale of 0-4. The scores for each item are then summed to produce a total score. The total score on the HAM-D is used to assess the severity of depression. Lower scores indicate less severe depression, while higher scores indicate more severe depression. Typical scoring interpretations: Below 7: Absence or remission of depression; 7-17: Mild depression; 18-24: Moderate depression; 25 and above: Severe depression
Quality of Life (Sleep Interference)
Daily Sleep Interference Log measures how much neuropathic pain impacts the patients sleep each night. The log is ranked on a 0 to 10 scale, 0 being pain didn't interfere with sleep and 10 being pain completely interfered with sleep, with a lower score representing a better outcome.
Functionality - Absenteeism
Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 1: Absenteeism (the percentage of work time missed); \*\*\*Only those being employed provided answer for absenteeism\*\*\* WPAI absenteeism scores are based 2-items (2 and 4); a score cannot be calculated if there is a missing response to the corresponding item. Question 2 represents time in hours lost due to health reasons while question 4 represents the time spent working. Time lost is divided by the total time (sum of 2 and 4) and then multiplied by 100 to express as a percentage. All WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Neuropathic Pain Medication Usage
Neuropathic Pain Medication Logs will measure changes in daily neuropathic pain. The log will record if daily neuropathic pain medications are used, the medication name(s), the strength(s) measured in mg, quantity measured by number of pills/sprays/etc. As well as if additional non-daily, typically OTC, pain medications were taken for neuropathy, the medication name(s), strength(s) measured in mg, quantity measured by number of pills/spray/etc. For this outcome, increases in any medication as well as new medications will be marked as "more" and numerically described with 1; decreases will be marked as "less" and numerically described as -1; no change will result in a 0. Total change will be summed per visit and later used as a percentage of participants positive (representing an increase in medication us) or negative (decrease in medication use) change. Any negative score will be considered a favorable outcome.
Allodynia Area Mapping (Von Frey)
von Frey 5.18 monofilament will be used to measure/map (cm²) out an area of neuropathic allodynia. The instrument will be used by pressing them against the neuropathic pain area and marking roughly 8 points with each. Then the points will be traced on two separate translucent papers, one for each instrument, to create two rough shapes to measure the areas. The area of the shape will be measured using a Compensating Polar Planimeter.
Allodynia Area Mapping (paint brush)
Paintbrush will be used to measure/map (cm²) out an area of neuropathic allodynia. The instrument will be used by pressing them against the neuropathic pain area and marking roughly 8 points with each. Then the points will be traced on two separate translucent papers, one for each instrument, to create two rough shapes to measure the areas. The area of the shapes will be measured using a Compensating Polar Planimeter.
QST Temperature Thresholds
Thermal Sensory Analyzer (Medoc Advanced Medical Systems, Minneapolis) will be used to measure cool, warm, cold, and hot temperature (°C) thresholds. The participant will first be asked to press the button when the increasing hot temperature becomes uncomfortable. This will be done 3 times and averaged to establish a threshold for the next portion. The thermode will heat up to the threshold temperature and remain their for a period of time. The participant will then rate their pain experienced via MVAS scale (0-10) with a 0 describing no pain and a 10 describing the worst pain experienced. A lower pain score will represent a better outcome and a higher score will represent a worse outcome.
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