Clinical trial NCT04000867: Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)
Official title: Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: diabetic foot pain
diabetic foot neuropathy
diabetic foot numbness
Lead sponsor: ZyGood LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland
name: Kaiser Permanente
First posted: 2019-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-site double blinded randomized control clinical trial
Primary purpose: TREATMENT

Brief summary: The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN) if used weekly for a month

Detailed description: The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN) if used weekly for a month The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN. No significant adverse reactions or side effects have been reported from the use of magnetic stimulation for the headache treatment or for the treatment of foot pain for about 20 patients. Some patients who have migraine headaches or foot pain have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications.

The initial safety and feasibility study did show it was both safe and effective but short term with most benefits wearing off after 1 week. Additionally in the initial study no placebo comparisons were made, therefore this study will consist of 20-blinded randomized patients. 10 will receive the TCMS treatment weekly and 10 will receive a sham treatment weekly both for 1 month.

Investigators believe that using the device weekly will relieve the foot pain caused by diabetic neuropathy over the course on 1 month compared with those receiving the sham treatment.

And to prove this hypothesis investigators will treat 10-blinded patients in the TCMS treatment group, they will be receiving active treatment as follows:

50 pulses to the sole of the patient's left (L) foot by placing the foot on top of the device with the heel touching the heel stop (the rear position)

Then followed by another 50 pulses to sole of the patient's L foot by either:

Moving the foot forward so the toes touch the toe stop (the forward position) or By placing the patients' foot under the pulsing deck (the under-deck position)

This procedure will then be repeated for the right (R) foot

10-blinded patients in the sham treatment group will use the same device. However, device will be switched into sham mode by the only un-blinded clinician in the study by pressing a small, non-descript button on the backside of the pulse generator. The treatment device in sham mode will produce a clicking sound once every 6 seconds like the TCMS treatment mode, but no magnetic pulses will be output.

Patients will receive the sham treatment the same as the TCMS treatment group, as described above and both groups will be completing a daily diary to rate and evaluate their pain and their quality of life for the month they participate in the study.

One side effect of this treatment may be some muscular jerking of the foot or the toes during the application of the magnetic pulses. This jerking will last only during the treatment and will not be painful or harmful.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of age.
2. Pain duration of more than one month.
3. Pain occurs daily.
4. Chronic DN associated bilateral foot pain and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.
5. Average Pain intensity ≥ 5 in each foot for at least 3 days at the time of enrollment.

Exclusion Criteria:

1. Life expectancy ≤ 6 months.
2. Oral pain medication doses or active ingredient has changed significantly\* in the prior 2 weeks.
3. Inability to walk at least 10 steps (with or without a cane/walker) before and after having to sit in a chair.
4. Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy, plantar fasciitis or arthritis of ankle and foot)
5. Inability to undergo study assessments or complete questionnaires independently.
6. Active psychological co-morbidities (i.e., uncontrolled schizophrenia).
7. Currently using an opioid medication for the treatment of foot pain\*\*.
8. Pregnancy
9. Inability to have MRI
10. Metal hardware and/or fragments in feet and ankles
11. Implanted pacemaker or a defibrillator, unless the device is considered MRI safe

    * A significant change for this study is defined as a 20% increase or decrease in dosing of the patient's medication dose and/or or a change in the medication class (adding or removing other types of medicines used to treat pain).

      * This exclusion is restricted to opioids, benzodiazepines and psychotropic.

Primary outcomes:
measure: Overall Pain reduction
timeFrame: 28 day +/- 2 days
Secondary outcomes:
measure: Pain reduction with in the first week
timeFrame: 1 week
measure: Improved Activities of daily living
timeFrame: 28 days +/- 2 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland
name: Kashif Munir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Ejaz Shamim, MD
role: PRINCIPAL_INVESTIGATOR
References: