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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument. |
|
| Control group | Active Comparator | Selected acupoints will be stimulated by the Hwato electroacupuncture instrument. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intelligent electroacupuncture instrument | Device | 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-â…¡ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of VAS scores from baseline to the completion of treatment | 0-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VAS score after each treatment | 0-2weeks | |
| Responder rate | 0-2weeks | |
| Use of non-steroidal antipyretic analgesics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yulan Ren, Professor | Chengdu University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610072 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31372917 | Derived | 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. |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Hwato electroacupuncture instrument | Device | 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. |
|
| 0-2weeks |
| Adverse events | 0-2weeks |
| West China Hospital, Sichuan University |
| Chengdu |
| Sichuan |
| 610072 |
| China |