Comparison of Intraneural FacilitationTM Therapy and Exercise on Patients with Type 2 Diabetes: A Single-Blind Randomized Trial

Abstract

Background: Diabetic peripheral neuropathy (DPN) is a prevalent complication of type 2 diabetes (T2D), associated with microvascular dysfunction and significant morbidity. Exercise is a cornerstone of diabetes care and has demonstrated benefits for neuropathic pain, whereas Intraneural FacilitationTM (INF®) therapy is a manual technique designed to enhance intraneural perfusion. This study compared the effects of INF® therapy and exercise on neuropathic pain qualities in adults with DPN. Methods: In this single-blinded randomized controlled trial, 38 adults with T2D and moderate to severe DPN were randomized to INF® therapy (n = 20) or standardized exercise (n = 18). Participants completed nine 60-min sessions over a period of six weeks. Neuropathic pain qualities were assessed using the Pain Quality Assessment Scale (PQAS) at baseline and post-treatment. Paired t tests, independent t tests, and linear mixed models adjusted for age and body-mass index (BMI) evaluated within- and between-group changes. Results: Both treatment groups demonstrated significant reductions in total PQAS scores (p = 0.001). INF® therapy produced improvements across paroxysmal, superficial, and deep pain domains, with reductions in descriptors such as shooting, sharp, electrical, numb, and unpleasant pain. Exercise led to selective improvements, including sharp, electrical, numb, sensitive, and unpleasant sensations associated with pain. Between-group analyses and mixed-effects models revealed no significant differences after adjusting for confounding factors. Conclusions: Both INF® therapy and exercise improved neuropathic pain qualities in adults with DPN. INF® therapy demonstrated broader within-group effects, suggesting its potential as a passive adjunct or alternative for patients unable to tolerate active exercise.