Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy

[All participants] First assessment session for research purposes only: Participants will complete the informed consent, VAS pain scale, HIPAA, and medical screening documents. Using the block randomization method, patients will be randomly assigned to the INF® Therapy only group or the INF® Therapy+ group by a research coordinator who will not be conducting any participant assessments. Ten participants will be recruited at a time with five randomly assigned to each of the two groups. Then all participants will be given brief explanations before administration of the questionnaires.

Participants will first be instructed to complete the visual analog scale (VAS) for pain, a subjective measure of pain intensity consisting of a 10-centimeter (cm) line with anchor statements on the left (no pain) and extreme pain on the right. Pain scores will be determined by measuring the distance in cm from "no pain" to the participant's anchor point. Participants who rate their pain level on the visual analog scale (VAS) as greater than seven out of ten level will be excluded from study participation due to poorly controlled pain.

Next, participants will complete a series of self-report questionnaires beginning with the CDAT questionnaire which gathers selected information on frequency of purposeful gluten consumption and self-efficacy to maintain compliance with a gluten-free diet.

The medical screening questionnaire will assess for important comorbid conditions that may influence outcomes.

Next, the PSQI is a clinical questionnaire assessing quality of sleep and sleep disturbances over the past month. The 19-item questionnaire provides seven component scores assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction.