Xiang Dongmei, Deng Lei, Zhou Rui, Zhang Xianjie, Zhou Yukai, Zhou Dan, Peng Yanhua
Department of Anesthesiology, Deyang People's Hospital, Deyang, China.
Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine，Translational Research Institute of Brain and Brain-Like Intelligence，Department of Anesthesiology and Periop, Shanghai, China.
JMIR Res Protoc. 2025 Jul 15;14:e68847. doi: 10.2196/68847.
Previous studies have demonstrated that ozone injection into the dorsal root ganglion significantly reduces pain scores associated with herpes zoster, suggesting its therapeutic potential for managing postherpetic neuralgia (PHN) via the intervertebral foramen epidural space. However, there are no specific reports addressing the treatment of herpes zoster and PHN by involving the thoracic and lumbar nerves under computed tomography (CT) guidance. Our research focuses on the effect of medical ozone administered through the intervertebral foramen epidural space on PHN.
This is a protocol for a prospective, randomized, controlled, and double-blind trial to detect whether the injection of medical ozone via the intervertebral foramen epidural space can reduce the incidence of PHN.
After signing the written informed consent, patients meeting eligibility criteria will be allocated into the medical ozone group and the control group in a 1:1 ratio according to the randomized grouping information, with 35 patients in each group. Patients in both groups accepting the surgical procedure under CT guidance will be injected with 5 mL of therapeutic liquid. Subsequently, medical ozone (30 μg/mL, 5 mL in each segment) will be slowly administered in the medical ozone group versus a sham procedure in the control group. The primary outcome will be the incidence of PHN 3 months after the subsidence of rashes and vesicles. The secondary outcomes will be the times of injection treatment, complications during the surgical procedure, times of remedial analgesia with ultrasound-guided nerve block, numerical rating score and tactile sensation, Hospital Anxiety and Depression Scale score, and the use of lidocaine cataplasms and oral analgesics before and after the surgical procedure under CT guidance. Data analyses between the 2 groups will be compared using the 2-sided Student t test or Wilcoxon Mann-Whitney test based on the viability of the normality assumption, while chi-square or Fisher exact test will be used to compare the categorical data.
This study was approved by the medical ethics committee of Deyang People's Hospital on February 27, 2024 (2024-03-002-K01). The first patient was enrolled on May 14, 2024. As of November 2024, 25 participants have been enrolled out of 70 who received screening. The analysis of the efficacy and safety data is expected to be performed in about May 2025 after all the patients have enrolled, with the approximate publication of results by September 2025.
If this exploratory trial proves effective, medical ozone administered via the intervertebral foramen epidural space may be utilized to aid in the recovery of the infected nerves and decrease the incidence of PHN in clinical settings. Positive outcomes will bolster the potential of employing medical ozone in the treatment of herpes zoster, thereby contributing to a reduction in the incidence of PHN.
Chinese Clinical Trial Registry ChiCTR2400084014; https://tinyurl.com/jk6p9hn2.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68847.
先前的研究表明，向背根神经节注射臭氧可显著降低与带状疱疹相关的疼痛评分，提示其通过椎间孔硬膜外间隙治疗带状疱疹后神经痛（PHN）的潜在可能性。然而，尚无关于在计算机断层扫描（CT）引导下累及胸段和腰段神经治疗带状疱疹和PHN的具体报道。我们的研究聚焦于通过椎间孔硬膜外间隙给予医用臭氧对PHN的影响。
本研究方案为一项前瞻性、随机、对照、双盲试验，旨在检测经椎间孔硬膜外间隙注射医用臭氧是否能降低PHN的发生率。
签署书面知情同意书后，符合纳入标准的患者将根据随机分组信息按1:1比例分配至医用臭氧组和对照组，每组35例。两组接受CT引导下手术的患者均注射5 mL治疗液。随后，医用臭氧组将缓慢注入医用臭氧（30 μg/mL，每节段5 mL），而对照组进行假手术。主要结局为皮疹和水疱消退3个月后PHN的发生率。次要结局包括注射治疗次数、手术过程中的并发症、超声引导下神经阻滞补救镇痛的次数、数字评分量表评分和触觉、医院焦虑抑郁量表评分，以及CT引导下手术前后利多卡因凝胶和口服镇痛药的使用情况。两组间的数据分析将根据正态性假设的可行性使用双侧Student t检验或Wilcoxon Mann-Whitney检验进行比较，而卡方检验或Fisher精确检验将用于比较分类数据。
本研究于2024年2月27日获得德阳市人民医院医学伦理委员会批准（2024 - 03 - 002 - K01）。首例患者于2024年5月14日入组。截至2024年11月，在接受筛查的70例患者中已有25例入组。预计在所有患者入组后约2025年5月进行疗效和安全性数据分析，结果约于2025年9月发表。
如果这项探索性试验证明有效，通过椎间孔硬膜外间隙给予医用臭氧可用于临床辅助感染神经的恢复并降低PHN的发生率。阳性结果将支持医用臭氧在治疗带状疱疹中的潜力，从而有助于降低PHN的发生率。
中国临床试验注册中心ChiCTR240008401; https://tinyurl.com/jk6p9hn2。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/68847。
