Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial.

Objective: To evaluate the effectiveness of intraneural facilitation (INF) for the treatment of diabetic peripheral neuropathy (DPN).

Methods: This single-blind, randomized clinical trial enrolled patients with type 2 diabetes mellitus and moderate-to-severe DPN symptoms below the ankle. Patients were randomly assigned to receive INF or sham treatment. In the INF group, trained INF physical therapists provided therapy for 50-60 min, three times a week for 3 weeks. Sham treatment consisted of patients believing they received anodyne therapy for 3 weeks. Pre- and post-treatment data were compared between the two groups for quality of life, balance, gait, protective sensory function and pain outcome measures.

Results: A total of 28 patients (17 males) were enrolled in the study (INF group  = 17; sham group  = 11). There was a significant decrease in the overall pain score in both the INF and sham groups over time, but the decrease was greater in the INF group (1.11 versus 0.82). Between-group comparisons demonstrated significant differences in unpleasant pain and protective sensory function. The INF group showed post-treatment improvements in protective sensory function and composite static balance score.

Conclusions: INF treatment improved pain perception, the composite static balance score and protective sensations in patients with DPN.Research Registry number: CNCT04025320.