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. 2025 Jan 6:15:1516262.
doi: 10.3389/fneur.2024.1516262. eCollection 2024.

Efficacy and safety of interferon-alpha 1b injection into the intervertebral foramen with ultrasonic guidance in patients with postherpetic neuralgia: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial

Hui-Min Hu #  1   2 , Wen-Hui Liu #  1   2 , Chen Li  1   2 , Qing Shi  1   2 , Chun-Hua Liu  1   2 , An-Xiang Liu  1   2 , Yi-Fan Li  2 , Yi Zhang  2 , Peng Mao  2 , Bi-Fa Fan  2
Affiliations

Efficacy and safety of interferon-alpha 1b injection into the intervertebral foramen with ultrasonic guidance in patients with postherpetic neuralgia: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial

Hui-Min Hu et al. Front Neurol. .

Abstract

Purpose: Postherpetic neuralgia (PHN) is a type of refractory neuropathic pain that causes significant suffering, disability, economic loss, and medical burden. In this study, we aim to evaluate the efficacy and safety of interferon (IFN)-α1b injection into the intervertebral foramen of patients with PHN.

Patients and methods: This is a study protocol for a randomized, double-blind placebo-controlled multicenter clinical trial. A total of 200 participants with PHN from 11 hospitals will be recruited and randomly assigned to the treatment group administered with IFN-α1b and control group treated with placebo in a 1:1 ratio. Both groups will also receive oral pregabalin 150 mg twice daily and lidocaine injection into the intervertebral foramen as conventional therapy. This trial will involve a screening period, a 2-week intervention, and a 3-month follow-up. The primary outcomes will include the visual analog scale score and duration of pain relief. The secondary outcomes will include the 36-item short-form, dosage and duration of painkillers taken, viral load of varicella-zoster virus DNA, humoral cytokine level, and dosage and frequency of rescue medication. All adverse events and severe adverse events will be assessed during the study.

Conclusion: This study is expected to provide evidence for the efficacy and safety of IFN-α1b injection into the intervertebral foramen in patients with PHN.

Clinical trial registration: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR240008996.

Keywords: foraminal injection; interferon-alpha 1b; postherpetic neuralgia; protocol; randomized controlled trail.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of the experimental: efficacy and safety of ultrasound-guided injection of interferon-alpha1b (IFN-alpha1b) into foramen of patients with postherpetic neuralgia.
See this image and copyright information in PMC

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