Qianyan Liu1,2,3, Xiaoliang Wu1, Jing Guo1, Jie Gao4, Bingyang Liu1, Yuhang Wang1, Minghui Xia5, Lixia Pei6,7, Jianhua Sun8,9. 1. Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China. 2. School of Medicine and Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, Jiangsu, China. 3. NMPA Key Laboratory for Research and Evaluation of Tissue Engineering Technology Products, Key Laboratory of Neuroregeneration of Jiangsu and Ministry of Education, Co-innovation Center of Neuroregeneration, Nantong University, Nantong, 226001, Jiangsu, China. 4. Hezhuang Street Community Health Service Center, Hangzhou, 311222, Zhejiang, China. 5. Department of Acupuncture, Affiliated Hospital of Nantong University, Nantong, 226001, Jiangsu, China. 6. Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China. 11801758@qq.com. 7. Acupuncture and Moxibustion Disease Project Group of China Evidence-Based Medicine Center of Traditional Chinese Medicine, Nanjing, 210029, Jiangsu, China. 11801758@qq.com. 8. Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu, China. jhsun@njucm.edu.cn. 9. Acupuncture and Moxibustion Disease Project Group of China Evidence-Based Medicine Center of Traditional Chinese Medicine, Nanjing, 210029, Jiangsu, China. jhsun@njucm.edu.cn.
Abstract
INTRODUCTION: The chronic neuropathic pain associated with postherpetic neuralgia (PHN) can last for several months or even many years, seriously affecting the affected person's work, sleep, mood, and daily life activities. In generaly, current treatments for PHN are at best limited and unsatisfactory, and adverse reactions are common, especially in elderly patients. Electroacupuncture (EA) is widely used clinically to manage painful diseases, but there remains a lack of evidence to support the effectiveness of EA on PHN. This study is designed to assess the efficacy and safety of EA on PHN, and to provide evidence-based medical evidence for EA treatment of PHN. METHODS: This multicenter, prospective, randomized controlled trial will recruit 448 patients with PHN at seven clinical centers. Multicenter stratified variable block randomization will be used, and the eligible patients will be randomly allocated in a ratio of 1:1 to the EA group or sham EA group. The EA group will receive 4 weeks of EA treatment, given as 30-min treatment sessions, once daily, 5 times per week, for a total of 20 treatments; the sham EA group will receive sham EA treatment under the same conditions. PLANNED OUTCOMES: The primary outcome measure is the 11-point Numeric Rating Scale pain score at week 4. The secondary outcome measures, including mechanical pain threshold, pain area of PHN, average number of pain episodes, the short-form McGill Pain Questionnaire 2, Zoster Brief Pain Inventory, the Depression, Anxiety, and Positive Outlook Scale, Patient Global Impression of Change, safety of EA, and use of concomitant medications, among others. The primary analysis of the outcomes will be the mixed-effect model with repeated measurement between groups on an intent-to-treat population. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04560361. Registered 23 September 2020 ( https://clinicaltrials.gov/ct2/show/NCT04560361?term=NCT04560361&draw=2&rank=1 ).
RCT Entities:
INTRODUCTION: The chronic neuropathic pain associated with postherpetic neuralgia (PHN) can last for several months or even many years, seriously affecting the affected person's work, sleep, mood, and daily life activities. In generaly, current treatments for PHN are at best limited and unsatisfactory, and adverse reactions are common, especially in elderly patients. Electroacupuncture (EA) is widely used clinically to manage painful diseases, but there remains a lack of evidence to support the effectiveness of EA on PHN. This study is designed to assess the efficacy and safety of EA on PHN, and to provide evidence-based medical evidence for EA treatment of PHN. METHODS: This multicenter, prospective, randomized controlled trial will recruit 448 patients with PHN at seven clinical centers. Multicenter stratified variable block randomization will be used, and the eligible patients will be randomly allocated in a ratio of 1:1 to the EA group or sham EA group. The EA group will receive 4 weeks of EA treatment, given as 30-min treatment sessions, once daily, 5 times per week, for a total of 20 treatments; the sham EA group will receive sham EA treatment under the same conditions. PLANNED OUTCOMES: The primary outcome measure is the 11-point Numeric Rating Scale pain score at week 4. The secondary outcome measures, including mechanical pain threshold, pain area of PHN, average number of pain episodes, the short-form McGill Pain Questionnaire 2, Zoster Brief Pain Inventory, the Depression, Anxiety, and Positive Outlook Scale, Patient Global Impression of Change, safety of EA, and use of concomitant medications, among others. The primary analysis of the outcomes will be the mixed-effect model with repeated measurement between groups on an intent-to-treat population. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04560361. Registered 23 September 2020 ( https://clinicaltrials.gov/ct2/show/NCT04560361?term=NCT04560361&draw=2&rank=1 ).
Authors: An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher Journal: Ann Intern Med Date: 2013-02-05 Impact factor: 25.391
Authors: R N Werner; A F Nikkels; B Marinović; M Schäfer; M Czarnecka-Operacz; A M Agius; Z Bata-Csörgő; J Breuer; G Girolomoni; G E Gross; S Langan; R Lapid-Gortzak; T H Lesser; U Pleyer; J Sellner; G M Verjans; P Wutzler; C Dressler; R Erdmann; S Rosumeck; A Nast Journal: J Eur Acad Dermatol Venereol Date: 2016-11-02 Impact factor: 6.166