The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy

NCT ID: NCT04025320

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-27
• Study Completion Date: 2020-12-10

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.

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Intraneural facilitation treatment for 50-60 minutes. 50 minutes if ultrasound received.

9 total treatment visits, 3 visits per week

• One 50-60 minute visit on Monday, Wednesday and Friday, for 3 weeks.

Group Type: EXPERIMENTAL

Intraneural Facilitation

Intervention Type: OTHER

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.

Group 2

SHAM treatment for 50-60 minutes. 50 minutes if ultrasound received. 9 total treatment visits, 3 visits per week

• One 50-60 minute visit on Monday, Wednesday and Friday, for 3 weeks.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

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.

Interventions

Intraneural Facilitation

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.

Intervention Type: OTHER

Sham

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Lee Berk

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee Berk, DrPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35922961 (View on PubMed)

Other Identifiers

5190128

Identifier Type: -

Identifier Source: org_study_id