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Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Sponsor: Assiut University
Summary
Painful diabetic peripheral neuropathy (DPN) is a frequent and disabling complication of diabetes that commonly causes persistent foot pain, sleep impairment, and decreased quality of life. While oral medications such as duloxetine are established treatment options, many patients experience incomplete pain control or encounter dose-limiting side effects. Perineural botulinum toxin type A (BTX-A) injection has emerged as an interventional approach designed to inhibit peripheral pain signaling with targeted, prolonged local effect. The purpose of this study is to compare the efficacy and safety of a single session of ultrasound-guided perineural BTX-A injection versus standard daily oral duloxetine therapy in relieving foot pain in patients with painful diabetic peripheral neuropathy. Participants will be randomly assigned to one of two groups using a double-dummy design to preserve blinding: * Group B (Botulinum Toxin): Receives a single session of ultrasound-guided perineural botulinum toxin type A injection around the ankle nerves plus daily oral placebo tablets for 12 weeks. * Group D (Duloxetine): Receives a single session of sham subcutaneous injection plus oral duloxetine tablets daily for 12 weeks (30 mg once daily for week 1, increased to 60 mg once daily for weeks 2-12). Participants will be followed for 6 months to evaluate changes in foot pain intensity on the Visual Analogue Scale (VAS) at 1 week, 1 month, 3 months, and 6 months. The study will also assess objective peripheral nerve function through bilateral nerve conduction studies (NCS) at baseline and 6 months, alongside evaluations of neuropathic pain scores, sleep quality, quality of life, and adverse effects.
Official title: Randomized Comparative Study of Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Key Details
Gender
All
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-11
Completion Date
2027-12
Last Updated
2026-10-20
Healthy Volunteers
No
Interventions
Botulinum Toxin Type A
A single session of ultrasound-guided perineural injection of botulinum toxin type A (total dose 100 units reconstituted in 5 mL preservative-free 0.9% normal saline) administered around the ankle nerves (posterior tibial, superficial peroneal, deep peroneal, sural, and saphenous nerves) of the affected lower limb.
Duloxetine
Oral duloxetine administered once daily for a total of 12 weeks: initiated at 30 mg once daily for the first week (Week 1), then escalated to 60 mg once daily for the remaining 11 weeks (Weeks 2-12).
Oral Placebo Tablet
Matching inert oral placebo tablets identical in appearance, packaging, and dosing schedule to duloxetine, taken once daily for 12 weeks.
Sham Perineural Injection
Single-session ultrasound-guided superficial subcutaneous injection of 5 mL 0.9% sterile saline without perineural deposition around the ankle nerves to preserve participant masking.