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Intraneural Facilitation vs Physical Therapy for Diabetic Neuropathy (INF Trial)

N/A

Recruiting

Led By Mark Bussell, DPT, OCS

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

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

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 weeks.

Awards & highlights

INF Trial Summary

This trial is studying how a non-invasive technique can reduce pain and improve balance in Type 2 Diabetic Peripheral Neuropathy (T2DPN) sufferers. 40 subjects will be monitored over 3 months to understand the physiological mechanisms behind the success.

Who is the study for?

This trial is for people aged 45-85 with moderate to severe type II diabetic neuropathy, experiencing symptoms like numbness and pain. Participants must have a physician's diagnosis and access to a smartphone. Excluded are those with conditions that could worsen in 6 months, such as chemotherapy patients or those with recent amputations.Check my eligibility

What is being tested?

The study compares Intraneural Facilitation™ (INF), a new non-invasive treatment, against standard physical therapy for diabetic neuropathy. Forty patients will be split into two groups to assess improvements in balance, pain, heart rate variability, blood oxygen levels, and inflammation over six weeks.See study design

What are the potential side effects?

While the trial interventions primarily involve physical therapy techniques which typically have minimal side effects compared to drug treatments, potential side effects may include discomfort at the site of treatment or increased soreness following therapy sessions.

INF Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 45 and 85 years old.

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I have type II diabetes with severe nerve pain or numbness.

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I have diabetes and feel numbness, tingling, or sharp pain in my feet or hands.

INF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Impact of INF® Therapy and Standard Physical Therapy on Heart Rate Variability

Secondary outcome measures

The impact of INF® Therapy and Standard Physical Therapy on blood flow

The impact of INF® Therapy and Standard Physical Therapy on inflammation

The impact of INF® Therapy and Standard Physical Therapy on neuropathy severity

INF Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard Physical Therapy Treatment GroupExperimental Treatment1 Intervention

Subjects will receive nine 60-minute standard physical therapy treatments during sessions 2 through 10.

Group II: Intraneural Facilitation Therapy Treatment GroupExperimental Treatment1 Intervention

Subjects will receive nine 60-minute INF® Therapy Treatments during sessions 2 through 10. INF® Therapy is a non-invasive treatment that helps eliminate pain, tingling, numbness, and other symptoms that come with neuropathy.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,944 Total Patients Enrolled

Mark Bussell, DPT, OCSPrincipal InvestigatorLoma Linda University Health

Media Library

Intraneural Facilitation Treatment™ Clinical Trial Eligibility Overview. Trial Name: NCT05577390 — N/A

Diabetic Neuropathy Research Study Groups: Standard Physical Therapy Treatment Group, Intraneural Facilitation Therapy Treatment Group

Diabetic Neuropathy Clinical Trial 2023: Intraneural Facilitation Treatment™ Highlights & Side Effects. Trial Name: NCT05577390 — N/A

Intraneural Facilitation Treatment™ 2023 Treatment Timeline for Medical Study. Trial Name: NCT05577390 — N/A

Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05577390 — N/A

Frequently Asked Questions

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

Is there a possibility for me to become involved in this experiment?

"This medical trial is accepting 40 individuals between the ages of 45 and 85 that suffer from non-insulin-dependent diabetes mellitus."

Answered by AI

Does this medical research study include individuals aged sixty and above?

"Applicants between the ages of 45 and 85 are eligible for this medical trial. In contrast, there are 51 clinical trials targeting individuals younger than 18 and 832 studies focusing on those over 65 years old."

Answered by AI

Is this clinical experiment currently seeking participants?

"Results from clinicaltrials.gov show no current enrollment opportunities for this trial, which was first posted on January 1st 2023 and last updated in late November of 2022. Despite the closure of enlistment for this medical evaluation, there are currently 948 other trials actively seeking applicants."

Answered by AI