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
PurposePostherpetic 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...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2024.1516262/full |
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| author | Hui-Min Hu Hui-Min Hu Wen-Hui Liu Wen-Hui Liu Chen Li Chen Li Qing Shi Qing Shi Chun-Hua Liu Chun-Hua Liu An-Xiang Liu An-Xiang Liu Yi-Fan Li Yi Zhang Peng Mao Bi-Fa Fan |
| author_facet | Hui-Min Hu Hui-Min Hu Wen-Hui Liu Wen-Hui Liu Chen Li Chen Li Qing Shi Qing Shi Chun-Hua Liu Chun-Hua Liu An-Xiang Liu An-Xiang Liu Yi-Fan Li Yi Zhang Peng Mao Bi-Fa Fan |
| author_sort | Hui-Min Hu |
| collection | DOAJ |
| description | PurposePostherpetic 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 methodsThis 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.ConclusionThis 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 registrationhttps://www.chictr.org.cn/indexEN.html, identifier ChiCTR240008996. |
| format | Article |
| id | doaj-art-99c148e68e8147a7ad705a8c4d41e4c2 |
| institution | DOAJ |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj-art-99c148e68e8147a7ad705a8c4d41e4c22025-08-20T02:54:00ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-01-011510.3389/fneur.2024.15162621516262Efficacy 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 trialHui-Min Hu0Hui-Min Hu1Wen-Hui Liu2Wen-Hui Liu3Chen Li4Chen Li5Qing Shi6Qing Shi7Chun-Hua Liu8Chun-Hua Liu9An-Xiang Liu10An-Xiang Liu11Yi-Fan Li12Yi Zhang13Peng Mao14Bi-Fa Fan15Graduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaPurposePostherpetic 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 methodsThis 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.ConclusionThis 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 registrationhttps://www.chictr.org.cn/indexEN.html, identifier ChiCTR240008996.https://www.frontiersin.org/articles/10.3389/fneur.2024.1516262/fullpostherpetic neuralgiainterferon-alpha 1bforaminal injectionrandomized controlled trailprotocol |
| spellingShingle | Hui-Min Hu Hui-Min Hu Wen-Hui Liu Wen-Hui Liu Chen Li Chen Li Qing Shi Qing Shi Chun-Hua Liu Chun-Hua Liu An-Xiang Liu An-Xiang Liu Yi-Fan Li Yi Zhang Peng Mao Bi-Fa Fan 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 Frontiers in Neurology postherpetic neuralgia interferon-alpha 1b foraminal injection randomized controlled trail protocol |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | postherpetic neuralgia interferon-alpha 1b foraminal injection randomized controlled trail protocol |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2024.1516262/full |
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