PMID- 35968361 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220816 IS - 1662-4548 (Print) IS - 1662-453X (Electronic) IS - 1662-453X (Linking) VI - 16 DP - 2022 TI - The CX-DZ-II intelligent electronic stimulator for neck pain caused by cervical spondylosis: A two-center, randomized, controlled, and non-inferiority trial. PG - 910574 LID - 10.3389/fnins.2022.910574 [doi] LID - 910574 AB - BACKGROUND: Electroacupuncture (EA) has been commonly used for the management of neck pain caused by cervical spondylosis (NPCS); however, current electrical instruments have limitations on intelligence, digitalization, and visualization. The intelligent electronic stimulator (CX-DZ-II) is a digital device with an evidence-based diagnosis and treatment system. This study aimed to investigate the efficacy and safety of the CX-DZ-II intelligent EA instrument for NPCS. MATERIALS AND METHODS: A total of 164 patients with NPCS [mean age (SD), 49.48 (13.47) years] were randomly assigned to receive 8 sessions (over 2 weeks) EA of the intelligent electronic stimulator (CX-DZ-II) or the regular electronic stimulator (SDZ-II). The primary outcome was the change of the visual analog scale (VAS) from baseline to 2 weeks of treatment. Secondary outcomes included mean scores of the VAS after each treatment in 1 week, responder rate, drug-usage rate of non-steroidal antipyretic analgesics (NSAAs), the occurrence rate of adverse events (AEs), proportions of apparatus with defect during treatment, and excellent rate of apparatus. RESULTS: The intelligent electronic stimulator (CX-DZ-II) was non-inferior to the regular electronic stimulator (SDZ-II) for changes from baseline in the VAS [3.36 vs. 3.23, with a difference of 0.17 (95% CI, -0.36 to 0.69), P < 0.025 for non-inferiority]. No between-group differences were found in outcomes of VAS in 1 week, overall responders, and drug-usage rate of NSAAs. The defect rate and excellent rate of the instrument were similar in the CX-DZ-II and SDZ-II groups. Adverse events occurred in 9 (10.84%) patients in the CX-DZ-II group and 4 (5.00%) patients in the SDZ-II group. CONCLUSION: The intelligent electronic stimulator (CX-DZ-II) was non-inferior to the regular electronic stimulator (SDZ-II) in relieving neck pain. The intelligent electronic stimulator (CX-DZ-II) is a promising non-inferior alternative instrument for NPCS. CLINICAL TRIAL REGISTRATION: [https://clinicaltrials.gov/], identifier [NCT030 05301]. CI - Copyright (c) 2022 Chen, Li, Xu, Liang, Zhang, Ren and Liang. FAU - Chen, Liping AU - Chen L AD - College of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Li, Dehua AU - Li D AD - Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Xu, Jing AU - Xu J AD - College of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Liang, Hao AU - Liang H AD - Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Zhang, Ya AU - Zhang Y AD - College of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Ren, Yulan AU - Ren Y AD - College of Chinese Classics, Chengdu University of Traditional Chinese Medicine, Chengdu, China. FAU - Liang, Fanrong AU - Liang F AD - College of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China. LA - eng SI - ClinicalTrials.gov/NCT00000030 PT - Journal Article DEP - 20220728 PL - Switzerland TA - Front Neurosci JT - Frontiers in neuroscience JID - 101478481 PMC - PMC9366011 OTO - NOTNLM OT - cervical spondylosis OT - electroacupuncture OT - neck pain OT - non-inferiority trial OT - randomized controlled trial COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/08/16 06:00 MHDA- 2022/08/16 06:01 PMCR- 2022/01/01 CRDT- 2022/08/15 04:13 PHST- 2022/04/01 00:00 [received] PHST- 2022/06/28 00:00 [accepted] PHST- 2022/08/15 04:13 [entrez] PHST- 2022/08/16 06:00 [pubmed] PHST- 2022/08/16 06:01 [medline] PHST- 2022/01/01 00:00 [pmc-release] AID - 10.3389/fnins.2022.910574 [doi] PST - epublish SO - Front Neurosci. 2022 Jul 28;16:910574. doi: 10.3389/fnins.2022.910574. eCollection 2022.