Mark Bussell, DPT, sits in front of physical therapy equipment

Intraneural Facilitation (INF) treatment effectively restores blood flow to damaged nerves, decreasing pain caused by diabetic peripheral neuropathy (DPN), according to a new study conducted by researchers at Loma Linda University Health. The study shows the quantitative results positively affect diabetes mellitus patients’ quality of life whose previous pain treatment option was medication utilization.

In 2017, the International Diabetes Federation estimated that 651.1 million adults between the ages of 65 to 99 years had diabetes mellitus, with 90 to 95% of those having Type 2 diabetes. Over 50% of patients with Type 2 diabetes suffer from DPN.

The previous treatment for DPN consisted of glycemic control, foot care, and pain management. The American Diabetes Association recommends medication utilization for the relief of painful DPN. Despite ongoing research, only modest benefits from pharmacology have been shown to slow disease progression and reduce pain associated with DPN.

Mark Bussell, DPT, developer of INF treatment and one of the lead researchers in this study, hypothesized that INF would decrease perceived pain, and improve balance, ambulation, quality of life, and protective sensory function in patients with moderate-to-severe DPN.

Reduced blood flow impacts DPN, and INF utilizes three holds or positions which widen tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain.

“There hasn’t been treatment to consistently reverse painful symptoms caused by Type 2 diabetes,” Bussell says. “It’s previously been said that there is no cure for DPN. We wanted to go for something that some people said could never be done.”

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 to 60 minutes, three times a week for three weeks. Sham treatment consisted of patients believing they received therapy for three 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.

A total of 28 patients were enrolled in the study: 17 in the INF group; 11 in the sham group. Researchers found a significant decrease in the overall pain score in both the INF and sham groups over time, but the decreased pain 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. There were no significant differences in the baseline characteristics of age, height, weight, and sex between the two groups.

“We’ve just discovered a new process towards manipulating the underappreciated vascular system,” Bussell says. “This is just the pilot study. We are thrilled to conduct further research showing success in treating other types of neuropathies with INF.”

This joint study was conducted by the Neuropathic Therapy Center and Loma Linda University School of Allied Health Professions. Bussell thanks his team and partnership with the School of Allied Health Professions for their expertise now and in future research opportunities. 

Learn more about the data researched in the study here. For more information about research at LLU, visit researchaffairs.llu.edu or call 909-558-8544.