The CX-DZ-II intelligent electronic stimulator for neck pain caused by cervical spondylosis: A two-center, randomized, controlled, and non-inferiority trial

Liping Chen; Dehua Li; Jing Xu; Hao Liang; Ya Zhang; Yulan Ren; Fanrong Liang

doi:10.3389/fnins.2022.910574

The CX-DZ-II intelligent electronic stimulator for neck pain caused by cervical spondylosis: A two-center, randomized, controlled, and non-inferiority trial

Front Neurosci. 2022 Jul 28:16:910574. doi: 10.3389/fnins.2022.910574. eCollection 2022.

Authors

Liping Chen¹, Dehua Li², Jing Xu¹, Hao Liang², Ya Zhang¹, Yulan Ren³, Fanrong Liang¹

Affiliations

¹ College of Acupuncture Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
² Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
³ College of Chinese Classics, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

Abstract

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].

Trial registration: ClinicalTrials.gov NCT00000030.

Keywords: cervical spondylosis; electroacupuncture; neck pain; non-inferiority trial; randomized controlled trial.

Associated data

ClinicalTrials.gov/NCT00000030