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Physical Therapy Technique

INF + Dietary Education for Diabetic Neuropathy

N/A

Recruiting

Led By Eric G Johnson, DSc, MS-HPEd

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe DPN (diabetic peripheral neuropathy) with symptoms below the knees of numbness, tingling, burning, sharp pain, and/or increased sensitivity

Independent in daily activities

Must not have

End stage congestive heart failure

Lower extremity amputations and open wounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and 3 months post enrollment.

Awards & highlights

No Placebo-Only Group

Summary

This trial compares INF, a physical therapy, with dietary education to see if it helps adults with DSPN improve circulation.

Who is the study for?

This trial is for adults aged 50-75 with Type II diabetes and moderate to severe diabetic peripheral neuropathy (DPN), specifically the distal symmetric polyneuropathy (DSPN) type. Participants should be able to perform daily activities without walking aids. Excluded are pregnant individuals, those with certain medical conditions or dietary restrictions, metal allergies, or undergoing specific treatments like chemotherapy.

What is being tested?

The study aims to assess if adding gluten-free dietary education enhances the benefits of Intraneural Facilitation™ (INF), a physical therapy technique that may improve circulation in people suffering from DSPN due to diabetes.

What are the potential side effects?

While INF is generally considered safe, potential side effects might include temporary discomfort at the treatment site. Dietary changes can sometimes lead to gastrointestinal adjustments or nutritional imbalances if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience numbness, tingling, or pain in my legs due to diabetes.

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I can take care of my daily needs by myself.

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I do not use any devices to help me walk.

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I have a specific type of nerve damage in my hands and feet.

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I have been diagnosed with Type II diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have advanced heart failure.

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I have had a leg or foot amputation or have open wounds.

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I have a long-term liver condition.

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I am currently undergoing chemotherapy, radiation, or dialysis.

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I am extremely overweight.

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I am currently experiencing inflammation.

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I have advanced COPD.

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My blood pressure is not well-controlled.

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My kidneys are in the final stage of failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and 3 months post enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and 3 months post enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and 3 months post enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Balance Stability

Neuropathy Severity

Pain Intensity Level

Secondary study objectives

Gluten Consumption Assessment

Pain Quality Assessment

Sleep Quality Assessment

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intraneural Facilitation® Therapy (INF® Therapy) + Dietary EducationExperimental Treatment1 Intervention

The INF® Therapy+ group will receive dietary education with weekly follow-up by a physical therapist either in person, or via email or text message. The INF® Therapy+ group will additionally receive meal preparation ideas and sample menus promoting a gluten-free diet.

Group II: Intraneural Facilitation® Therapy (INF® Therapy)Active Control1 Intervention

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.

0 / 14Eligibility criteria met