Comparing two methods for treating diabetic peripheral neuropathy
A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
This study is testing whether a new therapy called Intraneural Facilitation Therapy works better than standard physical therapy for treating nerve pain in people with Type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | Chemotherapy, Radiation |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05577390 on ClinicalTrials.gov |
What this trial studies
This study investigates the physiological mechanisms behind two treatment approaches for diabetic peripheral neuropathy in patients with Type 2 diabetes: Intraneural Facilitation Therapy (INF® Therapy) and standard physical therapy. Eligible participants aged 45 to 85 with moderate to severe neuropathy symptoms will be recruited and randomly assigned to one of the two treatment groups. Over six weeks, participants will undergo a series of assessments including pain quality, neuropathy scales, heart rate variability measurements, and blood tests to evaluate treatment effects. The study aims to enhance understanding of how these therapies work and their impact on patients' symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 85 with moderate to severe diabetic neuropathy symptoms.
Not a fit: Patients with other types of neuropathies, severe medical conditions, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from diabetic peripheral neuropathy.
How similar studies have performed: While Intraneural Facilitation Therapy has shown promise in improving symptoms, this specific comparative approach is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: Subjects with a medical condition predisposing them to medical decline during the next 6 months will be excluded from the study. Examples include: * 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
Where this trial is running
Loma Linda, California
- Loma Linda University Health Neuropathic Therapy Center — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Mark Bussell, DPT, OCS — Loma Linda University Health
- Study coordinator: Mark Bussell, DPT, OCS
- Email: ntcresearch@llu.edu
- Phone: 909-558-6799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.