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

Sponsor

American Association of Sensory Electrodiagnostic Medicine (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01979367

Collaborator

(none)

1,000

Enrollment

Locations

Arm

144

Duration (Months)

500

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

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 :

Mar 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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

Primary Outcome Measures

Primary Outcome: Scientific record of treatment success or failure [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Erie Medical and Rehab	Erie	Pennsylvania	United States	16509
2	Nerve Pain Centers of Western Pennsylvania	Pittsburgh	Pennsylvania	United States	15223

Sponsors and Collaborators

American Association of Sensory Electrodiagnostic Medicine

Investigators

Study Director: Michael Boyer, M.D., American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: Danielle Sanders, M.D., American Association of Sensory Electrodiagnostic Medicine
Study Chair: Chad Pfefer, M.D., American Association of Sensory Electrodiagnostic Medicine
Principal Investigator: Edward Snell, M.D., American Association of Sensory Electrodiagnostic Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

American Association of Sensory Electrodiagnostic Medicine

ClinicalTrials.gov Identifier:

NCT01979367

Other Study ID Numbers:

DTSC030113

First Posted:

Nov 8, 2013

Last Update Posted:

Jan 4, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Ischemia

Analgesics

Study Results

No Results Posted as of Jan 4, 2022