Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-03 @ 12:41 AM
Study NCT ID:
NCT01979367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling
Sponsor:
American Association of Sensory Electrodiagnostic Medicine
Organization:
Study Overview
Official Title:
To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTSC
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: