TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:

TransCutaneous Magnetic Stimulation (TCMS) for the Treatment of Foot Pain Caused By Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596203
• Other study ID #: HP-00081137
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). 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.

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). 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. Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications.

The investigators do not know whether this magnetic treatment will relieve the foot pain caused by diabetic neuropathy, so they will test this by applying 50 strong magnet pulses to the painful area of each foot. This procedure will be repeated onto three parts of each foot. First onto the bottom of the foot, then the top of the foot and then the back of the foot including a portion of the ankle. The effect on pain in each foot while walking for about 10 steps will be recorded before the study begins and periodically for 28 days. This testing will provide data as to any improvement in pain relief. If the participants' reported pain is reduced as a result of the magnetic treatment, then the magnetic pulses will have shown that they have reduced the pain. Additional studies will be needed to further investigate this treatment and to determine how to obtain statistically significant data as to whether this therapy reduces the foot pain caused by diabetic neuropathy.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years of age.

2. Prescription pharmacologic treatment is insufficient for treatment of pain.

3. Pain duration of more than one months.

4. Pain occurs daily.

5. Chronic DN associated pain that is located in bilateral feet and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.

6. Pain intensity = 5 in each foot 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) before and after having to sit in a chair.

4. Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy).

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Device:
• TransCutaneous Magnetic Stimulator (TCMS)
TCMS coils which are connected to feet and pulse generator. The generator will then be turned on to deliver 50 pulses at a pulse period of 6 seconds and at a pulse intensity of 100% to the bottom of the foot with the TCMS coil.

Locations

Country	Name	City	State
United States	University of Maryland Center for Diabetes and Endocrinology	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Numeric Pain Rating Scale, 0-10 with 0 being no pain, and 10 being worst pain ever experienced	1 to 28 days
Secondary	Functional status and Patient satisfaction with treatment	Descriptive Questionnaire to asses whether participant has improved functional status, such as ability to walk and whether participant is satisfied with treatment	1 to 28 days
Secondary	Changes in pain medication	Assessment of pain medications taken by participant prior to treatment and 28 days after treatment to deteremine if any of pain medications were increased, decreased or eliminated after treatment	1 to 28 days