NCT03005301

The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial evaluating the efficacy and safety of a new intelligent electroacupuncture instrument in treating neck pain caused by cervical spondylosis.

Detailed description

A total of 160 eligible patients will be included in this trial and randomly assigned to experimental group and control group in a 1:1 ratio. In experimental group, selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for control group, electroacupuncture treatment will be accomplished by a pre-existing electro-acupuncture instrument. The duration of treatment will be 2 weeks. The primary outcome is the change of visual analog scale score after one course of treatment. The secondary outcomes are visual analog scale score after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse events, defect rate of instrument, and excellent rate of instrument.

Conditions

• Acupuncture
• Neck Pain

Interventions

Type	Name	Description
DEVICE	intelligent electroacupuncture instrument	Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation. Trial instrument of this study is the CX-DZ-Ⅱ type intelligent electroacupuncture therapeutic instrument.Choice of acupuncture needle: one-off stainless acupuncture needle, which is 25\~40mm in length and 0.30\~0,38mm in diameter.Waveform: continuous-wave with frequency of 120\~250 times per minute and current intensity within patients' tolerance.Treatment time: each treatment time is 30 minutes.
DEVICE	Hwato electroacupuncture instrument	Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation. The Hwato electroacupuncture treatment instrument. Waveform: continuous-wave with frequency of 120\~250 times per minute and current intensity within patients' tolerance. Treatment time: each treatment time is 30 minutes.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-03-01
• Completion: 2018-06-01
• First posted: 2016-12-29
• Last updated: 2018-06-01

Locations

2 sites across 1 country: China