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

May 31, 2018 updated by: Chengdu University of Traditional Chinese Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Affliated Hospital of Chengdu University of Traditional Chinese Medicine
      • Chengdu, Sichuan, China, 610072
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.
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.
Active Comparator: Control group
Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of VAS scores from baseline to the completion of treatment
Time Frame: 0-2 weeks
0-2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS score after each treatment
Time Frame: 0-2weeks
0-2weeks
Responder rate
Time Frame: 0-2weeks
0-2weeks
Use of non-steroidal antipyretic analgesics
Time Frame: 0-2weeks
0-2weeks
Adverse events
Time Frame: 0-2weeks
0-2weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

West China Hospital

Investigators

  • Principal Investigator: Yulan Ren, Professor, Chengdu University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 24, 2016

First Submitted That Met QC Criteria

December 24, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016XL007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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