AcupunctureNCT03005301
The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
A study testing intelligent electroacupuncture instrument and Hwato electroacupuncture instrument in people with Acupuncture and Neck Pain, run by Chengdu University of Traditional Chinese Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupuncture, Neck Pain
- What is being tested?
- intelligent electroacupuncture instrument and Hwato electroacupuncture instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Affliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
West China Hospital, Sichuan University
Chengdu, Sichuan, 610072
About this study
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.
Read the 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
- Being tested
- intelligent electroacupuncture instrument, Hwato electroacupuncture instrument
- Keywords
- electroacupuncture instrument
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intelligent electroacupuncture instrumentDevice
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.
Hwato electroacupuncture instrumentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument. Receives: Device: intelligent electroacupuncture instrument |
| Control group | Active comparator | Selected acupoints will be stimulated by the Hwato electroacupuncture instrument. Receives: Device: Hwato electroacupuncture instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of VAS scores from baseline to the completion of treatment
Measured: 0-2 weeks
Secondary outcomes (4)
VAS score after each treatment
Measured: 0-2weeks
Responder rate
Measured: 0-2weeks
Use of non-steroidal antipyretic analgesics
Measured: 0-2weeks
Adverse events
Measured: 0-2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
- Investigators
- Yulan Ren, Professor, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005301
- Sponsor's protocol ID
- 2016XL007
- Status last verified
- May 2018
- First submitted
- 24 Dec 2016
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31372917
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
- ClinicalTrials.gov ID
- NCT03005301
- Acronym / sponsor ID
- 2016XL007
- Conditions
- Acupuncture, Neck Pain
- Keywords
- electroacupuncture instrument
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: intelligent electroacupuncture instrumentSelected acupoints will be stimulated by the new intelligent electro-acupuncture instrument. |
| Control group | Active comparator | Device: Hwato electroacupuncture instrumentSelected acupoints will be stimulated by the Hwato electroacupuncture instrument. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intelligent electroacupuncture instrumentChoice 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 | Experimental group |
| Hwato electroacupuncture instrumentChoice 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. | Device | Control group |
Primary outcome
The change of VAS scores from baseline to the completion of treatment
Time frame: 0-2 weeks
4 secondary outcomes
VAS score after each treatment
Time frame: 0-2weeks
Responder rate
Time frame: 0-2weeks
Use of non-steroidal antipyretic analgesics
Time frame: 0-2weeks
Adverse events
Time frame: 0-2weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Derived from this study: PubMed 31372917Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulan Ren, Professor principal investigator
Chengdu University of Traditional Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intelligent electroacupuncture instrument and Hwato electroacupuncture instrument in people with Acupuncture and Neck Pain, run by Chengdu University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of VAS scores from baseline to the completion of treatment (time frame: 0-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.