TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy

Phase 1

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Device: TransCutaneous Magnetic Stimulator (TCMS)

• Registration Number: NCT03596203
• Lead Sponsor: University of Maryland, Baltimore

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). 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.

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). 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.

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-23
• Study Start: 2018-11-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	TransCutaneous Magnetic Stimulator (TCMS)	-

Primary Outcome Measures

Name	Time	Method
Pain level	1 to 28 days	Numeric Pain Rating Scale, 0-10 with 0 being no pain, and 10 being worst pain ever experienced

Secondary Outcome Measures

Name	Time	Method
Functional status and Patient satisfaction with treatment	1 to 28 days	Descriptive Questionnaire to asses whether participant has improved functional status, such as ability to walk and whether participant is satisfied with treatment
Changes in pain medication	1 to 28 days	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

Trial Locations

Locations (1)

University of Maryland Center for Diabetes and Endocrinology; 🇺🇸 Baltimore, Maryland, United States