The purpose of this study is to determine if near infrared light therapy is effective in
decreasing pain in patients with painful peripheral neuropathy.
Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This
study is designed to evaluate the effectiveness of near infrared photoenergy therapy in the
treatment of pain in axonal peripheral neuropathy. This will be compared with a
placebo(sham) device. 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
- 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 CASE IV;
quantitative sudomotor axon reflex test (QSART); 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 COX 2 inhibitors
- 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
- 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 HbA1c greater than 9%, and/or 10% of fasting
blood sugars greater than 300 mg/dl for the week prior to enrollment.