The effects of botulinum toxin type A injection on pain symptoms, quality of life, and sleep quality of patients with diabetic neuropathy: A randomized double-blind clinical trial

  • Hossein Salehi Department of Plastic and Reconstructive Surgery, School of Medicine, Rafsanjan University of Medical Sciences, Iran Clinical Research Development Center, Ali Ibn Abi Talib Hospital, Rafsanjan University of Medical Sciences, Iran
  • Moein Moussaei School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
  • Zahra Kamiab Department of Social Medicine, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran Clinical Research Development Unit, Ali Ibn Abi Talib Hospital, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
  • Alireza Vakilian Department of Neurology, School of Medicine, University of Medical Sciences, Rafsanjan, Iran Non-Communicable Diseases Research Center, Ali Ibn Abi Talib Hospital, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
Keywords: Diabetic Neuropathies, Botulinum A Toxin, Quality of Life, Sleep


Background: Neuropathic pain is one of the most common problems in patients with diabetes mellitus (DM). In this study, the effect of botulinum toxin type A (BTX-A) on neuropathic pain, quality of sleep, and quality of life of diabetic patients with sensorimotor polyneuropathy was studied.

Methods: This randomized placebo-controlled trial study was carried out in a double-blind (patient-researcher) method. The study was performed on 32 patients with type 2 DM. Neuropathy was confirmed by Douleur Neuropathique 4 (DN4) Questionnaire and nerve conduction study (NCS). The patients were randomly assigned to two intervention and control groups based on the random numbers table. After selecting the subjects, we used 36-Item Short Form Health Survey (SF-36), Neuropathic Pain Scale (NPS), Visual Analogue Scale (VAS), and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after 3 months of 100 units BTX-A injection (as intervention group) or same amount of chloride sodium (as control group) to the subjects' feet. The data were analyzed by SPSS software using independent two-sample t-test, chi-square test, and one-way repeated measures analysis of variance (ANOVA).

Results: 12 male and 20 female patients participated in this study. There was a significant difference in the mean VAS, PSQI, physical dimension of the SF-36, and some NPS indices over time (12 weeks) (P < 0.001).

Conclusion: The results of this study showed that BTX-A reduced neuropathic pain and improved the quality of life and sleep in people with diabetic neuropathy.


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How to Cite
Salehi H, Moussaei M, Kamiab Z, Vakilian A. The effects of botulinum toxin type A injection on pain symptoms, quality of life, and sleep quality of patients with diabetic neuropathy: A randomized double-blind clinical trial. Iran J Neurol. 18(3):99-107.
Original Article(s)