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.

Plain language summary

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.

Keywords::

• acupoint
• diabetic neuropathy
• hypertonic saline injection
• perineural

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2022-0042

Author contributions

All authors contributed to designing, data collection, processing and analysis of the research and finally writing this manuscript.

Acknowledgments

This manuscript was a part of the thesis of Nina Heidari (No. 15205) that was approved by the vice-chancellor of research, Shiraz University of Medical Sciences, Shiraz, Iran. The study method was approved by the Medical Ethics Committee of Shiraz University of Medical Sciences (SUMS) with the reference number ‘IR.SUMS.MED.REC.1397.132’. The authors would like to thank the Research Consultation Center (RCC) of Shiraz University of Medical Sciences and the center for developmental clinical research of Namazee Hospital.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data. Deidentified, individual data that underlie the results reported in this article (text, tables, figures and appendices), along with the study protocol will be available from the corresponding author following publication.