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

Primary Purpose

Acupuncture, Neck Pain

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

intelligent electroacupuncture instrument

Hwato electroacupuncture instrument

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring electroacupuncture instrument

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Affliated Hospital of Chengdu University of Traditional Chinese Medicine
West China Hospital, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.

Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.

Outcomes

Primary Outcome Measures

The change of VAS scores from baseline to the completion of treatment

Secondary Outcome Measures

VAS score after each treatment

Responder rate

Use of non-steroidal antipyretic analgesics

Adverse events

Full Information

NCT ID

NCT03005301

First Posted

December 24, 2016

Last Updated

May 31, 2018

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03005301

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

West China Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acupuncture, Neck Pain

Keywords

electroacupuncture instrument

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.

Intervention Type

Device

Intervention Name(s)

intelligent electroacupuncture instrument

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Hwato electroacupuncture instrument

Intervention Description

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.

Primary Outcome Measure Information:

Title

The change of VAS scores from baseline to the completion of treatment

Time Frame

0-2 weeks

Secondary Outcome Measure Information:

Title

VAS score after each treatment

Time Frame

0-2weeks

Title

Responder rate

Time Frame

0-2weeks

Title

Use of non-steroidal antipyretic analgesics

Time Frame

0-2weeks

Title

Adverse events

Time Frame

0-2weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yulan Ren, Professor

Organizational Affiliation

Chengdu University of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Affliated Hospital of Chengdu University of Traditional Chinese Medicine

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

Facility Name

West China Hospital, Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31372917

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.

Results Reference

derived

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

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