Actively Recruiting

Phase Not Applicable
Age: 45Years - 85Years
All Genders
ID05577390

A Physiologic Comparison of Intraneural Facilitation Therapy and Standard Physical Therapy for Peripheral Neuropathy in Type 2 Diabetes

Led by Loma Linda University · Updated on 2025-11-19

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating two treatment approaches for Peripheral Neuropathy in people with Type 2 Diabetes, a common and costly complication causing symptoms like pain, numbness, and tingling. This study aims to better understand how Intraneural Facilitation Therapy (INF4 Therapy), a non-invasive manual technique, compares to standard physical therapy in improving neuropathy symptoms and underlying physiological functions. Participants will be randomly assigned to one of two groups: one receiving nine 60-minute sessions of INF4 Therapy, which involves specific manual holds to improve blood flow in nerves, and the other receiving nine 60-minute sessions of standard physical therapy focused on muscle stretching, balance, and strengthening exercises. Treatments occur over 6 weeks during 11 study visits, including initial and follow-up assessments. Throughout the study, participants will undergo various tests including pain assessments, heart rate variability monitoring using the Welltory App, vascular imaging, blood oxygen and flow measurements, and blood draws to measure inflammation and blood sugar control. These evaluations occur at several visits to monitor changes and treatment effects. The study will analyze these measures to understand how each therapy impacts nerve function, blood flow, and inflammation over the 6-week period.

CONDITIONS

Brief Title

A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Who Can Participate

Age: 45Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 45 and 85
  • Diagnosed moderate to severe type II diabetic neuropathy with symptoms such as numbness, tingling, burning, sharp pain, or increased sensitivity
  • Diagnosis confirmed by a physician
  • Access to a cellphone with Android 5.0 or later or iOS 14.0 or later
Not Eligible

You will not qualify if you...

  • Medical conditions likely to cause decline in the next 6 months, such as chemotherapy or radiation
  • Lower extremity amputations
  • Open wounds
  • Active drug or alcohol misuse
  • Chronic liver disease
  • Active inflammations
  • Neuropathies not related to diabetes, including B12 deficiency and Charcot Marie Tooth
  • Morbid obesity
  • Pregnancy
  • Taking beta blockers
  • Unable to maintain steady fingers or operate a cellphone
  • Smoking or using marijuana
  • Having a pacemaker
  • Allergies to cobalt, chrome, or nickel

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility confirmation

Treatment

Duration - Approximately 6 weeks

Participants receive nine 60-minute sessions of either Intraneural Facilitation Therapy or standard physical therapy to treat peripheral neuropathy symptoms.

11 sessions with assessments on sessions 1, 2, 5, 10, and 11

Trial Site Locations

Total: 1 location

1

Loma Linda University Health Neuropathic Therapy Center

Loma Linda, California, United States, 92350

Actively Recruiting

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Research Team

M

Mark Bussell, DPT, OCS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.

https://pubmed.ncbi.nlm.nih.gov/8737210

Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition.

Pouya Saeedi, Inga Petersohn, Paraskevi Salpea...

https://pubmed.ncbi.nlm.nih.gov/31518657

Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep.

Mugdha Gore, Nancy A Brandenburg, Ellen Dukes...

https://pubmed.ncbi.nlm.nih.gov/16256902

Microcirculatory vasomotor changes are associated with severity of peripheral neuropathy in patients with type 2 diabetes.

Pi-Chang Sun, Cheng-Deng Kuo, Lin-Yang Chi...

https://pubmed.ncbi.nlm.nih.gov/23241514

Proinflammatory cytokines predict the incidence of diabetic peripheral neuropathy over 5 years in Chinese type 2 diabetes patients: A prospective cohort study.

Hangping Zheng, Wanwan Sun, Qi Zhang...

https://pubmed.ncbi.nlm.nih.gov/33385123