Clinical trial NCT04025320: The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Official title: The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
* Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
* ≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
* Between age 50-75 years

Exclusion Criteria:

* Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
* Any lower extremity amputations or wounds
* Documented active alcohol and/or drug misuse
* Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
* DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
* Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
* Other severe chronic medical condition requiring active treatment
* Morbidly Obese patients
* Pregnancy (self reported)

Primary outcomes:
measure: Pain Quality Assessment Scale
timeFrame: change between baseline and 5 weeks
Secondary outcomes:
measure: Limits of Stability
timeFrame: change between baseline and 5 weeks
measure: Zeno Walkway
timeFrame: change between baseline and 5 weeks
measure: Sensory organization test (SOT)
timeFrame: change between baseline and 5 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Lee Berk, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahba K, Berk L, Bussell M, Lohman E, Zamora F, Gharibvand L. Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial. J Int Med Res. 2022 Aug;50(8):3000605221109390. doi: 10.1177/03000605221109390.