Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT02104466
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02104466
Study Brief:
Protocol Section:
NCT02104466