Effect of Gluten-Free Dietary Education and Intraneural Facilitation™ on Quality of Life in People With Diabetic Neuropathy
Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation) focused on measuring Intraneural Facilitation, Dietary Education, Gluten-free diet, Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria
Participants in this study must be/have:
- Older adults between 50 to 75 years of age
- Willing to actively improve neuropathy symptoms
- Diagnosed with Type II diabetes
- Moderate to severe DPN (diabetic peripheral neuropathy) with symptoms below the knees of numbness, tingling, burning, sharp pain, and/or increased sensitivity
- Distal Symmetric Polyneuropathy (DSPN) form of DPN confirmed by a physician
- Independent in daily activities
- Do not use any assistive device for walking such as a cane, walker, or wheelchair
Exclusion Criteria
- Currently consuming a mainly plant-based or gluten-free diet
- Known allergy to chrome, nickel, or cobalt
Any of the following medical conditions:
- Current regimen of chemotherapy, radiation, or dialysis
- Lower extremity amputations and open wounds
- Documented active drug and/or alcohol misuse
- End stage renal failure
- End stage congestive heart failure
- Uncontrolled hypertension
- Chronic liver disease
- Advanced chronic obstructive pulmonary disease
- Active inflammations
- Other types of neuropathies not associated with diabetes including B12 deficiency
- Any other chronic medical conditions requiring active treatment
- Morbid obesity
- Pregnancy (self-reported)
Sites / Locations
- Loma Linda University HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intraneural Facilitation (INF) + Dietary Education
Intraneural Facilitation (INF)
The INF+ group will receive dietary education with weekly follow-up by a physical therapist either in person, or via email or text message. The INF+ group will additionally receive meal preparation ideas and sample menus promoting a gluten-free diet.
INF™ is a manual therapy technique that consists of three components. The first is the pressurization or facilitation hold which biases circulation more consistently in the nerves, which is thought to "pressurize the entire system" The secondary hold attempts to stretch the innervated structure, pulling apart the tough dividing membrane and allowing the pressurized blood flow to transport from the outside "holding" chamber to the endoneurium and push open the closed capillary beds next to the nerve axons. Once capillaries surrounding the nerves are pressurized, the circulation needs to be induced up the neural connective tissue. A separate set of pressure points or "holds" are performed distal to the secondary holds to ensure the circulation is drawn up the inflamed capillary beds using the Bernoulli principle.