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Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling (DTSC)

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ClinicalTrials.gov Identifier: NCT01979367
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2013
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
American Association of Sensory Electrodiagnostic Medicine

Study Description
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Brief Summary:
Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity pathologies derived from neurological ischemia disorders using the combination of Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS) therapies.

Condition or disease Intervention/treatment Phase
Lower Extremity Swelling Acute Device: Anodyne Not Applicable

Detailed Description:

Although there are a number of pain disorders, associated with back, or lower extremity pain and swelling, the American Association of Sensory Electrodiagnostic Medicine (AASEM/ DTSC) study programs will accumulate received data following a protocol of treatment performed for the purpose of eliminating pain, reducing swelling, and accelerating recovery periods as well as to record the success or failure and/or improvement of the malfunctioning body part.

  • Condition: Neuropathic Pain, Tingling or Numbness derived from neurological Ischemia
  • Intervention: Treatments of Monochromatic Infrared Photo Energy (MIRE) in combination with Electronic Signal Treatment (TENS) therapy
  • Study Type: Interventional

  • Study Design:

    1. Allocation: Non-Randomized
    2. Endpoint Classification: Efficacy Study
    3. Intervention Model: Single Group Assignment
    4. Masking: Open Label
    5. Primary Purpose: Scientific record of treatment success or failure

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders
Study Start Date : March 2012
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anodyne
To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)
 Device: Anodyne
Subjects will be treated with MIRE therapy using the Anodyne® device within 72 hours of previous treatments, and in accordance with the Anodyne® package insert indications for use 30 to 45 minutes professional units on power setting of 8,. In addition, patients will undergo TENS therapy with the use of either the Avazzia® Pro Sport or TENS 3000 (for no less than 30 mins, both on label) in accordance with the indications for use of each TENS device, for a minimum of 15 minutes at the subjective site for pain and each vertebrae nerve base, when impairment is confirmed with the objective Small Pain Fiber (SPF) Nerve Conduction Study (NCS) test performed.


Outcome Measures
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Primary Outcome Measures :
  1. Scientific record of treatment success or failure [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In the investigator's judgment, a high probability of 5 year survival and compliance with the study visit schedule.

Ability to comprehend and sign an informed consent document prior to study enrollment.

Exclusion Criteria:

  • Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.
Contacts and Locations
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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): NCT01979367


Locations
United States, Pennsylvania
Erie Medical and Rehab
Erie, Pennsylvania, United States, 16509
United States, Texas
Gerstenberg.Clinic
Port Neches, Texas, United States, 77651
Silsbee Family Medicine PA
Silsbee, Texas, United States, 77656
Sponsors and Collaborators
American Association of Sensory Electrodiagnostic Medicine
Investigators
Study Director: Michael Boyer, M.D. Mimbres Memorial Hospital
Principal Investigator: Danielle Sanders, M.D. Erie Medical and Rehab
Principal Investigator: K. Paul Gerstenberg, D.O. gerstenberg.clinic
Study Chair: Chad Pfefer, M.D. American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: Doyce Cartrett, M.D. Silsbee Family Medicine PA
More Information
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Additional Information:
American Association of Sensory Electrodiagnostic Medicine (Sponsor)  This link exits the ClinicalTrials.gov site

Responsible Party: American Association of Sensory Electrodiagnostic Medicine
ClinicalTrials.gov Identifier: NCT01979367     History of Changes
Other Study ID Numbers: DTSC030113
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs