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

Kyan Sahba, Lee Berk, Mark Bussell, Everett Lohman, Francis Zamora, Lida Gharibvand, Kyan Sahba, Lee Berk, Mark Bussell, Everett Lohman, Francis Zamora, Lida Gharibvand

Abstract

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 n = 17; sham group n = 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.

Keywords: Diabetes; intraneural facilitation; neuropathy; physiotherapy.

Conflict of interest statement

Declaration of conflicting interest: Dr Mark Bussell is the inventor on several patent applications filed by the Loma Linda University Medical Center that covers the subject matter of intraneural facilitation presented in this paper.

Figures

Figure 1.
Figure 1.
Flow chart showing progress through enrolment, randomization and analysis of patients with type 2 diabetes mellitus and diabetic peripheral neuropathy that were enrolled in a prospective, randomized, single-blind study of intraneural facilitation (INF) for the treatment of diabetic peripheral neuropathy. Each patient had a chance to randomly draw group 1 or group 2 therapy (INF or sham therapy).
Figure 2.
Figure 2.
Results of the Semmes–Weinstein monofilament test showing the mean percentage ‘yes’ responses pre- and post-treatment for the third and fifth distal phalanx in patients with type 2 diabetes mellitus and diabetic peripheral neuropathy that were enrolled in a prospective, randomized, single-blind study of intraneural facilitation (INF) for the treatment of diabetic peripheral neuropathy. Data presented as mean; Wilcoxon’s signed-rank test.

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