TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy

NCT ID: NCT03596203

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-07-30

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.

Conditions

Diabetic Neuropathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

TransCutaneous Magnetic Stimulator (TCMS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Kashif Munir

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kashif Munir, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Center for Diabetes and Endocrinology

Baltimore, Maryland, United States

Countries

United States

References

Rao VP, Kim YK, Ghazi A, Park JY, Munir KM. Efficacy of recurrent transcutaneous magnetic stimulation in the treatment of diabetic peripheral neuropathy: Multicenter randomized trial. Pain Pract. 2023 Nov;23(8):914-921. doi: 10.1111/papr.13269. Epub 2023 Jul 3.

Reference Type: DERIVED

PMID: 37395169 (View on PubMed)

Rao VP, Satyarengga M, Lamos EM, Munir KM. The Use of Transcutaneous Magnetic Stimulation to Treat Painful Diabetic Neuropathy. J Diabetes Sci Technol. 2021 Nov;15(6):1406-1407. doi: 10.1177/19322968211026943. Epub 2021 Jul 3. No abstract available.

Reference Type: DERIVED

PMID: 34218718 (View on PubMed)

Other Identifiers

HP-00081137

Identifier Type: -

Identifier Source: org_study_id