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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01979367
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2013
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
American Association of Sensory Electrodiagnostic Medicine

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 8, 2013
Last Update Posted Date May 21, 2019
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
Scientific record of treatment success or failure [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Scientific record of treatment success or failure [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT01979367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling
Official Title  ICMJE To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lower Extremity Swelling Acute
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Anodyne
To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)
Intervention: Device: Anodyne
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01979367
Other Study ID Numbers  ICMJE DTSC030113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party American Association of Sensory Electrodiagnostic Medicine
Study Sponsor  ICMJE American Association of Sensory Electrodiagnostic Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Boyer, M.D. American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: Danielle Sanders, M.D. American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: K. Paul Gerstenberg, D.O. American Association of Sensory Electrodiagnostic Medicine
Study Chair: Chad Pfefer, M.D. American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: Doyce Cartrett, M.D. American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: Ajith Nair, M.D. American Association of Sensory Electrodiagnostic Medicine
PRS Account American Association of Sensory Electrodiagnostic Medicine
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP