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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT00125268
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00125268
Study Brief:
Protocol Section:
NCT00125268