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Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy

NCT05165368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-08-14

No results posted yet for this study

Summary

The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation® Therapy (INF® Therapy) (a physical therapy technique being evaluated that may help improve circulation) versus INF® Therapy only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).

Conditions

  • Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)

Interventions

OTHER

Intraneural Facilitation® Therapy (INF® Therapy)

INF® Therapy plus dietary education with weekly follow-up by a physical therapist. Includes meal preparation ideas and sample menus promoting a gluten-free diet.

OTHER

INF® Therapy

INF® Therapy only (INF® Therapy is a manual therapy technique that consists of three components. The first is the pressurization or facilitation hold which biases circulation more consistently in the nerves, which is thought to "pressurize the entire system" The secondary hold attempts to stretch the innervated structure, pulling apart the tough dividing membrane and allowing the pressurized blood flow to transport from the outside "holding" chamber to the endoneurium and push open the closed capillary beds next to the nerve axons. Once capillaries surrounding the nerves are pressurized, the circulation needs to be induced up the neural connective tissue. A separate set of pressure points or "holds" are performed distal to the secondary holds to ensure the circulation is drawn up the inflamed capillary beds using the Bernoulli principle.)

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Eric G Johnson, DSc, MS-HPEd · Department of Physical Therapy School of Allied Health Professions, Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-05-20
Completion
2025-05-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165368 on ClinicalTrials.gov