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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Acupuncture Instrument Group | Experimental | 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. |
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| Manual Acupuncture Group | Active Comparator | Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument. |
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| Sham Acupuncture Group | Sham Comparator | Patients in the SA group will receive non-invasive acupuncture to avoid de qi. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Acupuncture Manipulation Therapeutic Instrument | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Pei, Doctor | Contact | 00862164385700 | 3534 | longhuaacup@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Pei, Doctor | Shanghai University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LongHua Hospital Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Manual Acupuncture | Other | Manual acupuncture to acheive de qi. |
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| Sham Acupuncture | Other | Sham acupuncture to avoid de qi. |
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| Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) |