Effects of Medical Ozone Injection via Intervertebral Foramen Epidural Space on Postherpetic Neuralgia: Protocol for a Randomized Controlled and Double-Blind Clinical Trial
Notice bibliographique
Résumé
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400084014; https://tinyurl.com/jk6p9hn2. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68847.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,021 | 0,021 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,002 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».