Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 15, 2024
Date Accepted: Jun 17, 2025
Effects of medical ozone injection via intervertebral foramen epidural space on postherpetic neuralgia: protocol for a randomized, controlled and double-blind clinical trial
ABSTRACT
Background:
Postherpetic neuralgia (PHN) has a significant impact on people’s quality of life. Even though researchers and clinicians have made numerous attempts and efforts to reduce the incidence of PHN, and several interventions are already being used, it is very difficult to completely prevent the development of PHN.
Objective:
This is a protocol for a prospective, randomized, controlled and double-blind to detect whether injection of medical ozone via intervertebral foramen epidural space can reduce the incidence of PHN.
Methods:
After signing the written informed consent, patients meeting eligibility criteria will be allocated into medical ozone group (group MZ) and control group (group C) in a 1:1 ratio according to the randomized grouping information, with 35 patients in each group. Patients in group MZ will be injected with 10 ml of therapeutic liquid and 5 ml of medical ozone (30 μg/ml) in each segment, while patients in group C will be only injected with 10 ml of treatment liquid. The primary outcome will be the incidence of PHN at 3 months after the subsidence of rashes and vesicles. The secondary outcomes will be the times of injection treatment, complications during surgical procedure, times of remedial analgesia using ultrasound-guided nerve block, NRS score and tactile sensation, HADS score, and the use of lidocaine cataplasms and oral analgesics before and after the injection treatment.
Results:
The first patient has been enrolled on May 14, 2024. As of November 2024, a total of 25 participants were enrolled out of 70 who received screening. The analysis of the efficacy and safety data is expected to be carried out after all patients enrolled, about in May 2025, with an approximate publication of results by September 2025.
Conclusions:
This trials will detect that injection of medical ozone via intervertebral foramen epidural space can potentially help infected nerve recover and reduce the incidence of PHN, enhancing clinical treatment outcomes. Positive results would support the prospect of using medical ozone in the treatment of herpes zoster, helping reducing the incidence of PHN. Clinical Trial: ChiCTR2400084014.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.