Neck Pain Clinical Trial
Official title:
The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
NCT number | NCT03005301 |
Other study ID # | 2016XL007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | June 2018 |
Verified date | May 2018 |
Source | Chengdu University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Affliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan |
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Chengdu University of Traditional Chinese Medicine | West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of VAS scores from baseline to the completion of treatment | 0-2 weeks | ||
Secondary | VAS score after each treatment | 0-2weeks | ||
Secondary | Responder rate | 0-2weeks | ||
Secondary | Use of non-steroidal antipyretic analgesics | 0-2weeks | ||
Secondary | Adverse events | 0-2weeks |
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