Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT00125268

Run by

Mayo Clinic

People needed

30

Starts

2005-07-01

Expected to finish

2010-04-01

Last updated by the study team

2012-09-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ages 18-85; able to give informed consent
• Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.
• Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem [Q-Sweat]); neurology specialty examination; and neuropathy impairment score (NIS) of less than 25.
• Stable pharmacotherapy for neuropathic pain for at least two weeks.
• Optimal pharmacotherapy has been achieved.
• Subjects cannot be on Cyclooxygenase-2 (COX 2) inhibitors
• Pain Visual Analog Scale (VAS) of greater than or equal to 4/10
• Subject has provided written informed consent
• Not currently using transcutaneous electrical nerve stimulation (TENS)
• Not currently receiving acupuncture

You may not qualify if…

• Pregnant or likely to become pregnant
• Current diagnosis of cancer
• Neuropathy impairment score (NIS) of greater than 25.
• Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).
• Unstable diabetes mellitus defined as a hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.