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TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT03596203
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kashif Munir, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Device: TransCutaneous Magnetic Stimulator (TCMS) Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TransCutaneous Magnetic Stimulation (TCMS) for the Treatment of Foot Pain Caused By Diabetic Neuropathy
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group 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.




Primary Outcome Measures :
  1. Pain level [ Time Frame: 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 :
  1. Functional status and Patient satisfaction with treatment [ Time Frame: 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

  2. Changes in pain medication [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596203


Contacts
Contact: Medha Satyarengga, M.D. 443-682-6873 MSatyarengga@som.umaryland.edu
Contact: Kashif Munir

Locations
United States, Maryland
University of Maryland Center for Diabetes and Endocrinology Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Medha Satyarengga, M.D.    443-682-6873      
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Kashif Munir, M.D. University of Maryland

Responsible Party: Kashif Munir, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT03596203     History of Changes
Other Study ID Numbers: HP-00081137
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases