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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and 3 months post enrollment.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Balance Stability
Neuropathy Severity
Pain Intensity Level
Secondary outcome measures
Gluten Consumption Assessment
Pain Quality Assessment
Sleep Quality Assessment
+2 more

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.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,914 Total Patients Enrolled
Eric G Johnson, DSc, MS-HPEdPrincipal InvestigatorDepartment of Physical Therapy School of Allied Health Professions, Loma Linda University

Media Library

Intraneural Facilitation (INF) (Physical Therapy Technique) Clinical Trial Eligibility Overview. Trial Name: NCT05165368 — N/A
Diabetic Neuropathy Research Study Groups: Intraneural Facilitation® Therapy (INF® Therapy) + Dietary Education, Intraneural Facilitation® Therapy (INF® Therapy)
Diabetic Neuropathy Clinical Trial 2023: Intraneural Facilitation (INF) Highlights & Side Effects. Trial Name: NCT05165368 — N/A
Intraneural Facilitation (INF) (Physical Therapy Technique) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05165368 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of a youthful age capable of participating in this investigation?

"This clinical trial is seeking patients in their golden years, with ages ranging from 50 to 75."

Answered by AI

Is there any capacity for additional participants in this research?

"Indeed, the information on clinicialtrials.gov evinces that this medical study is currently recruiting patients. It was initially posted on August 1st 2023 and subsequently revised four days later. The researchers are aiming to enroll 70 individuals from a single site."

Answered by AI

How many participants can be accepted into this research program?

"Affirmative. Clinicaltrials.gov data reveals that this medical study, initially posted on the 1st of August 2021, is actively seeking volunteers for participation. This trial requires 70 test subjects from a single site in order to move forward."

Answered by AI

What outcomes is this investigation striving to realize?

"This clinical trial's primary endpoint is an evaluation of neuropathy severity from the point of study enrollment to three months after. Secondary outcomes encompass state-trait anxiety level, as measured by STAI-form Y; pain quality assessment using a modified version of the Neuropathic Pain Scale; and sleep quality assessments via Pittsburg Sleep Quality Index (PSQI)."

Answered by AI

Who is eligible to take part in this research study?

"For eligibility in this research, participants must possess diabetic neuropathy and fall within the age range of 50 to 75. Approximately 70 individuals will be admitted into this study."

Answered by AI

Who else is applying?

What site did they apply to?
Loma Linda University Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have numbness and tingling and often feel as though I’m walking on rocks and I’m seeking relief.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy
Eric Johnson 2023. "Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05165368.
All > Neuropathy > Diabetic Neuropathy
~31 spots leftby Dec 2024
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