Efficacy of perineural hypertonic saline injection versus acupoints of foot in the management of diabetic neuropathy: a multicenter, double-blinded randomized controlled trial.

ABSTRACT

Aim: Painful diabetic polyneuropathy is one of the most common disabling problems worldwide. We aimed to determine if a perineural injection of hypertonic saline compared with foot acupoints decreased the neuropathic pain score in patients with diabetes. Patients & methods/materials Patients were assigned to receive either perineural or acupoints injection of hypertonic saline 5% in their feet for three weekly sessions. Douleur Neuropathique 4 (DN4) questionnaire for neuropathic pain was assessed. Results: Both groups observed a significant reduction of the DN4 score throughout 8 weeks of follow-up. Conclusion: Both perineural and acupoints hypertonic saline injections of the foot could improve neuropathic pain in patients with diabetes.

We conducted a double blinded randomized clinical trial in 30 diabetic patients with painful neuropathic pain to determine if a perineural injection of hypertonic saline compared with foot acupoints decreased the neuropathic pain score in patients with diabetes. Subjects were assigned to receive either perineural (near Sural, Saphenous and Tibial nerves) or acupoints (ST41, ST44, GB40) injection of hypertonic saline 5% in one foot, keeping the other foot as control. Each patient underwent an injection at baseline followed by two injections, one week apart. The primary outcome was an assessment tool for neuropathic pain, called Douleur Neuropathique 4 questionnaire (DN4) score. It was measured before, during and 8 weeks after intervention. A significant reduction of DN4 score in perineural group and in the acupoint group throughout an 8 weeks follow-up was observed compared with the contralateral foot which was considered as the control group. The study revealed no significant differences between the perineural and the acupoints groups according to DN4 score. In conclusion, both perineural and acupoints of the foot hypertonic saline injections could improve neuropathic pain in diabetic patients with neither being superior to each other. The Clinical Trial Registration number was IRCT20170517034008N1.