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Comparing Intraneural Facilitation Therapy and Standard Physical Therapy for Diabetic Neuropathy

This study is comparing two ways to treat peripheral neuropathy (nerve damage) in people with Type 2 Diabetes: Intraneural Facilitation Therapy (INF® Therapy) and standard physical therapy. INF® Therapy uses gentle manual holds to encourage blood flow in the nerves. Standard physical therapy involves exercises like stretching, balance, and strengthening. Researchers want to understand the body's responses to both treatments. You may be able to join if you are 45-85 years old, have moderate to severe Type 2 diabetic neuropathy confirmed by a doctor, and have a smartphone. The main goal is to see how these treatments affect your heart rate variability (how your heart rate changes over time), which will be measured over about 6 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 40 participants to compare two different physical therapy approaches.
What's involved
You would have assessments on the first, second, fifth, tenth, and eleventh sessions. This includes questionnaires, vascular analysis, and nerve tests. You would also take heart rate variability measurements using a smartphone app daily around treatment sessions.
Compensation
Not stated in the trial record.
Follow-up
Your heart rate variability will be measured through study completion, an average of 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05577390

A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy

Recruiting
NAAges 45–85InterventionalTreatment
Loma Linda University
~40 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:Intraneural Facilitation Therapy TreatmentStandard Physical Therapy Treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Impact of INF® Therapy and Standard Physical Therapy on Heart Rate Variability
Measured over Through study completion, an average of 6 weeks.

Conditions

Peripheral Neuropathy With Type 2 Diabetes

Explore related trials

Peripheral NeuropathyType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Mark Bussell, DPT, OCS · PRINCIPAL_INVESTIGATOR · Loma Linda University Health

Who to contact

Mark Bussell, DPT, OCS
[email protected]
909-558-6799
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Between the ages of 45 and 85
Moderate to severe type II diabetic neuropathy with one or more symptoms including: numbness, tingling, burning, sharp pain, and/or increased sensitivity.
Diagnosis confirmed by a physician.
Cellphone access with Android 5.0 and up or iOS 14.0 or later.

Exclusion

Chemotherapy
Radiation
Lower extremity amputations
Open wounds
Documented active drug and or alcohol misuse
Chronic liver disease
Active inflammations
Other types of neuropathies not associated with 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 ingesting marijuana
Having a pacemaker
Allergies to cobalt, chrome, or nickel

What this trial measures

  • The Impact of INF® Therapy and Standard Physical Therapy on Heart Rate VariabilityThrough study completion, an average of 6 weeks.

    This is a composite measurement combining electrocardiogram and Welltory App measurements. Heart rate variability (HRV) is the variation in the time interval between consecutive heartbeats and can be used to assess the current state of the nervous system. HRV measures will include LF, HF, LF/HF ratio, SDNN, SDANN, RMSSD, and NN50. The calculation of these variables allows HRV to be quantified. A normal result is between 25 to 50 milliseconds while an abnormal result is less than or greater than that range.