The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to explore the effects of a new
      treatment known as Intraneural facilitation (INF) on Diabetes Mellitus Type 2 (DMT2) subjects
      who have moderate - severe below ankle neuropathy symptoms. Since INF has shown success in
      the clinic and significant improvements have been found in a recent pilot study, this study
      aims to further explore these effects on DMT2 subjects suffering from DPN. The investigators
      would like to investigate if INF improves blood flow in the foot, if it decreases the pain
      and improves the sensation, and if it improves the overall quality of life.
    

Detailed description: 
      The demographic data (age, height, gender, and weight) will be collected from each subject.
      All subjects will go through the following protocol: First, subjects will complete
      pre-testing measurements consisting of 5 tests; Pain Quality Assessment Scale,
      Semmes-Weinstein Monofilaments, NeuroCom SMART Balance Master, Quality of Life- Diabetic
      Neuropathy Scale (QOL- DN), and Zeno Walkway. Patients will then be randomized into two
      groups and blinded by the treatment. Patients who draw "Group 1" will be given the INF
      treatment and patients who draw "Group 2" will be given the SHAM treatment. Patients will
      then be completing 3 weeks of INF treatment, or SHAM treatment for 3 visits per 3 week,
      totaling 9 treatment visits. Post treatment, patients will then return for the same 5
      measurements completed at baseline.
    

Intervention name(s): Intraneural Facilitation; Sham
Intervention type(s): Other; Other
Intervention description(s): Intraneural Facilitation utilizes three manual holds. Firstly, the contralateral joint is placed in a maximal loose-pack position to pressurize the nervous system and bias circulation from the artery into the epineurium. Now that we have increased this pressure we begin the secondary hold to bias the increased epineurial blood into the transperineurial vessels that bridge the epiperineum and the endoneurial capillaries of the site being treated. Now that the pressure has increased into the open endoneurial capillaries, the goal is to open up ischemic endoneurial capillaries and this is hypothesized to open by providing the third hold. The third hold is known as the sub hold and encourages blood flow through ischemic endoneurial capillaries that have increased resistance/pressure through the application of bernoulli's principle. This treatment will take 50-60 minutes.; A physical therapist will perform the SHAM light therapy at the same site as the INF therapy location, at the Neuropathic Treatment Center. The SHAM light therapy will last 50-60 minutes and consists of using an anodyne unit for application of near-infrared light therapy. The unit will not be switched on, but the pads will be placed on the subject and the subject will be blinded to the unit being on. The anodyne therapy pads will be placed in the following locations on the affected lower limb: two on the plantar aspect of the foot in a T formation and one pad on the medial and lateral side of the calf. A double folded towel will be wrapped around the subject's foot at the electrode sites to blind the subject's from the light not emitting from the electrodes, due to the anodyne unit being off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment