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

NCT04025320 | Completed

• 1 other identifier: 5190128
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Pain Quality Assessment Scale

  It is a self-report tool derived from Neuropathic Pain Scale to evaluate the quality of neuropathic pain. After reading the introduction of the questionnaire, subjects will then measure their pain on a numeric scale 0= "no pain" or "no painful sensation" to 10 = "worst imaginable pain sensation" . A zero score represents the best outcome and a 10 is the worst outcome. This questionnaire takes approximately 10 minutes.

  change between baseline and 5 weeks

Secondary Outcomes (3)

• Limits of Stability

  change between baseline and 5 weeks

• Zeno Walkway

  change between baseline and 5 weeks

• Sensory organization test (SOT)

  change between baseline and 5 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Other: Intraneural Facilitation

Group 2

SHAM COMPARATOR

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.

Other: Sham

Interventions

Intraneural Facilitation 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 1

Sham 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.

Group 2

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Related Publications (1)

• 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.

  PMID: 35922961 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Lee Berk, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 18, 2019
• Study Start: September 27, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

US (1)