Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125268
Status:
TERMINATED
Last Update Posted:
2012-09-05
First Post:
2005-07-27
Brief Title:
Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase III Double Blind Randomized Placebo-controlled Study to Assess the Efficacy of Adjunct Monochromatic Near-infrared Photoenergy MIRE in Patients With Painful Axonal Peripheral Neuropathy
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy The hypothesis of the study was that the percentage of subjects with at least 40 improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy MIRE treatment than for sham treatment
Detailed Description:
Pain is a very common symptom between 65-80 in patients with peripheral neuropathy This study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy MIRE in the treatment of pain in axonal peripheral neuropathy This will be compared with a placebo sham device
The MIRE is a FDA approved drug-free non-invasive medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy MIRE through contact with the skin The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation MIRE is also thought to increase local levels of nitric oxide NO which may decrease pain levels
Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks Response will be measured during and after the treatment period
The MIRE is a FDA approved drug-free non-invasive medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy MIRE through contact with the skin The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation MIRE is also thought to increase local levels of nitric oxide NO which may decrease pain levels
Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks Response will be measured during and after the treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None