Clinical trial NCT03005301: The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
Official title: The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Neck Pain
Keywords: electroacupuncture instrument
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2016-12-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 75 years old.
* Subject is diagnosed with CS of neck type or nerve-root type by clinical and medical imaging examination.
* A history of recurrent episodes of neck pain (one or more neck pain per month lasting for more than 3 months).
* Pain intensity is more than 3 points on a VAS upon recruitment.
* Subject or his guardian comprehend the aims of this trial, promise not to accept other relative treatments during the trial, and sign the informed consent.

Exclusion Criteria:

* Subject has acute neck trauma.
* Previous medical history of neck trauma treated by surgery, or neurological deficit, or congenital and developmental spinal disorders, or systemic bone diseases, or systemic joint diseases (e.g. joint slippage).
* Subject is diagnosed with carotid artery dissection.
* Subject is unable to express clearly self-feelings (e.g. subject with severe cerebrovascular accident sequelae).
* Subject has infection in acupuncture region.
* A history of acupuncture treatment for neck pain in the previous 1 week.
* Use of non-steroidal antipyretic analgesics in the previous 3 days.
* Subject has to use central analgesics or narcotic analgesics (e.g. Tramadol, Morphine, Dolantin) during the period of clinic trial.
* Use of various ointments or medicinal liquors with functions of promoting blood circulation and/or easing pain.
* Use of oral and intravenous medicines with functions of opening blood vessels and providing nutrition to nerve.
* Combinations of severe systematic diseases (e.g. a history of myocardial infarction, or severe hepatic and renal dysfunction, or acute infectious diseases, or malignant tumors, or severe mental disturbance diseases in previous 12 months).
* Intolerance of acupuncture and electro-acupuncture.
* Allergy to acupuncture.
* Female in pregnancy or lactation.
* Subject participate other clinic trials in previous 3 months.
* Subject is considered to be unsuited to this trial by investigators.

Primary outcomes:
measure: The change of VAS scores from baseline to the completion of treatment
timeFrame: 0-2 weeks
Secondary outcomes:
measure: VAS score after each treatment
timeFrame: 0-2weeks
measure: Responder rate
timeFrame: 0-2weeks
measure: Use of non-steroidal antipyretic analgesics
timeFrame: 0-2weeks
measure: Adverse events
timeFrame: 0-2weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Yulan Ren, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen ZH, Liang FR, Yang MX, Li DH, Zhang Y, Ren YL. Effect and Safety of CX-DZ-II Intelligent Electroacupuncture Therapeutic Instrument for Neck Pain Caused by Cervical Spondylos: Study Protocol for A Randomized Controlled Trial. Chin J Integr Med. 2020 May;26(5):375-381. doi: 10.1007/s11655-019-3038-2. Epub 2019 Aug 1.