Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Study Overview
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Brief Summary
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The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36).

Detailed Description
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Based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. The biocompatibility of shock wave was detected by Massachusetts General Hospital Needle sensation scale ((Massachusetts General Hospital Acupuncture Sensation Scale, MASS)). The visual analogue pain score ((Visual analogue scale, VAS)), neck disability index scale ((Neck Disability Index,NDI) and short form 36-item questionnaire (SF-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical Spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.

Official Title
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Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Conditions
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Cervical Spondylosis

Intervention / Treatment
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* Device: Digital Acupuncture Manipulation Therapeutic Instrument
* Other: Manual Acupuncture
* Other: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neck pain with the diagnosis of cervical spondylotic radiculopathy; Aged between 18-70 years; Have not participated in any drug clinical trials within the last month; Voluntarily joining this study with informed consents Exclusion Criteria: A history of cervical spine trauma or have received cervical spine surgery; Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression; Cervical spondylosis in urgent need of surgery; Pregnant women and lactating women; A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Acupuncture Instrument Group<br>The needles will be stimulated manually to achieve de qi (a compositional sensation including soreness, numbness, distention and heaviness) and then paired electrodes from the digital acupuncture instrument will be attached to the needle handles and another two adjunct acupoints by the research assistant. The electric current will be increased until the needles begin to vibrate slightly. | Device: Digital Acupuncture Manipulation Therapeutic Instrument<br>* The device is based on the characteristics of traditional acupuncture manipulation of Shanghai School of Traditional Chinese Medicine, and absorbs the information of the techniques of famous experts, modulates the stimulation waveform of the electroacupuncture device by modulating the signal, and realizes the digitization of acupuncture technique information.<br>|
| Active Comparator: Manual Acupuncture Group<br>Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument. | Other: Manual Acupuncture<br>* Manual acupuncture to acheive de qi.<br>|
| Sham Comparator: Sham Acupuncture Group<br>Patients in the SA group will receive non-invasive acupuncture to avoid de qi. | Other: Sham Acupuncture<br>* Sham acupuncture to avoid de qi.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue scale（VAS） | A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions. | Change from baseline VAS at 4weeks | 
| Visual Analogue scale（VAS） | A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions. | Change from baseline VAS at 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index（NDI） | A scale that helps a patient to quantify neck disability. | Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) | 
| short form 36-item questionnaire, SF-36 | a set of 36 questions abstracted from the much longer set of several hundred used in household interview surveys of the U.S. National Health Survey. The SF36 questions are a convenient abbreviation, used for screening purposes to assess the physical function, social function, role limitation, mental health, energy, vitality, pain, and subjective perception of health status. They have been tested and found to be valid and reliable. | Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital acupuncture manipulation therapeutic instrument, cervical spondylosis