The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- The change of VAS scores from baseline to the completion of treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental group
Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.
Intervention: intelligent electroacupuncture instrument (Device)
Control group
Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.
Intervention: Hwato electroacupuncture instrument (Device)
Outcomes
Primary Outcomes
The change of VAS scores from baseline to the completion of treatment
Time Frame: 0-2 weeks
Secondary Outcomes
- VAS score after each treatment(0-2weeks)
- Responder rate(0-2weeks)
- Use of non-steroidal antipyretic analgesics(0-2weeks)
- Adverse events(0-2weeks)