Lead Sponsor

University of California, San Francisco

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•English, Spanish, or Cantonese speaking
•Diagnosed with type 2 diabetes mellitus
•Distal lower limb pain present for at least three months
•A score of 4 or greater on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) for the pain of diabetic peripheral neuropathy at least four days a week before randomization
•Pain characterized as burning, shooting, or stabbing in nature
•Ability to understand study procedures and willingness to comply with them for the entire length of the study
•A score of less than 8 on the Semmes-Weinstein monofilament test
•Stable use of pain control medications for PDN in the one month prior to screening (e.g. no change in prescription) or no use of pain control medications for PDN within the past one month

•Substance abuse (as assessed by the Simple Screening Instrument for Substance Abuse)
•Unstable medical condition (e.g. severe pulmonary disease, myocardial infarction, severe depressive symptoms)
•Electrical therapy (e.g. TENS unit) or patch treatment (e.g. lidocaine or capsaicin) for PDN used within the past two weeks
•Acupuncture, moxibustion, cupping or herbal medicine for PDN used within the past two weeks
•Pregnancy, planning a pregnancy or breast-feeding
•Inability or unwillingness to comply with this study protocol, assessed prior to randomization