A Treatment Protocol for Patients With Diabetic Peripheral Neuropathy
Leonard and colleagues found that the MIRE treatments resulted in a significant increase in sensation in individuals with baseline sensation of 6.65 Semmes-Weinstein Monofilament (SWM) after 6 and 12 active treatments as well as a decrease in neuropathic symptoms as measured by the Michigan Neuropathy Screening Instrument.16 Prendergast and colleagues noted improved electrophysical changes in both large and small myelinated nerve fibers of patients with DPN following 10 MIRE treatments.17 When studying 49 patients with DPN, Kochman and colleagues found 100% of participants had improved sensation after 12 MIRE treatments when tested with monofilaments.18
An additional benefit of MIRE treatment is that it can be safely performed at home once the patient is educated on proper use and application. Home DPN treatment has the potential to decrease the burden this population places on health care systems by reducing provider visits, medication, hospitalization secondary to pain, ulceration, fall injuries, and amputations.
Methods
This was a prospective, case series pilot study designed to measure changes in patient pain levels using the visual analog scale (VAS) and Pain Outcomes Questionnaire-VA (POQ-VA), degree of protective sensation loss as measured by SWM, and fall risk as denoted by Tinetti scores from entry to 6 months. Informed consent was obtained prior to treatment, and 33 patients referred by primary care providers and specialty clinics met the criteria and enrolled in the study. Twenty-one patients completed the entire 6-month study. The nonparametric Friedman test with a Dunn’s multiple comparison (DMC) post hoc test was used to analyze the data from the initial, 4-week, 3-month, and 6-month follow-up visits.
Setting and Participants
The study was performed in the Outpatient Physical Therapy Department at WJBDVAMC. Veterans with DPN who met the inclusion/exclusion criteria were enrolled. Inclusion criteria specified that the participant must be referred by a qualified health care provider for the treatment of DPN, be able to read and write in English, have consistent transportation to and from the study location, and be able to apply MIRE therapy as directed at home.
Exclusion criteria were subjects for whom MIRE or exercise were contraindicated. Subjects were excluded if they had medical conditions that suggested a possible decline in health status in the next 6 months. Such conditions included a current regimen of chemotherapy, radiation therapy, or dialysis; recent lower extremity amputation without prosthesis; documented active alcohol and/or drug misuse; advanced chronic obstructive pulmonary disease as defined as dyspnea at rest at least once per day; unstable angina; hemiplegia or other lower extremity paralysis; and a history of central nervous system or peripheral nervous system demyelinating disorders. Additional exclusion criteria included hospitalization in the past 60 days, use of any apparatus for continuous or patient-controlled analgesia; history of chronic low back pain with documented radiculopathy; and any change in pertinent medications in the past 60 days, including pain medications, insulin, metformin, and anti-inflammatories.
Interventions
Subjects participated in a combined physical therapy approach using MIRE and a standardized balance program. Patients received treatment in the outpatient clinic 3 times each week for 4 weeks. The treatment then continued at the same frequency at home until the scheduled 6-month follow-up visit. Clinic and home treatments included application of MIRE to bilateral lower extremities and feet for 30 minutes each as well as performance of a therapeutic exercise program for balance.
In the clinic, 2 pads from the MIRE device (Anodyne Therapy, LLC, Tampa, FL) were placed along the medial and lateral aspect of each lower leg, and an additional 2 pads were placed in a T formation on the plantar surface of each foot, per the manufacturer’s recommendations. The T formation consisted of the first pad placed horizontally across the metatarsal heads and the second placed vertically down the length of the foot. Each pad was protected by plastic wrap to ensure proper hygiene and secured. The intensity of clinic treatments was set at 7 bars, which minimized the risk of burns. Home treatments were similar to those in the clinic, except that each leg had to be treated individually instead of simultaneously and home MIRE units are preset and only function at an intensity that is equivalent to around 7 bars on the clinical unit.
The standardized balance program consisted of a progression of the following exercises: ankle alphabet/ankle range of motion, standing lateral weight shifts, bilateral heel raises, bilateral toe raises, unilateral heel raises, unilateral toe raises, partial wall squats, and single leg stance. Each participant performed these exercises 3 times per week in the clinic and then 3 times per week at home following the 12th visit.
