CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Intraneural Facilitation® Therapy (INF® Therapy) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05165368
NCT05165368N/ACompleted

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

Loma Linda University·interventional·Posted Dec 21, 2021·Updated Aug 14, 2025

In Brief

A clinical study evaluating Intraneural Facilitation® Therapy (INF® Therapy) and INF® Therapy for Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation). Completed, enrolled 46 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 21, 2021
Enrollment StartAug 1, 2023
Primary CompletionMay 20, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.5 years ago

Interventions

Intraneural Facilitation® Therapy (INF® Therapy)other

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.

INF® Therapyother

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.)