Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    150
  • sponsor
    Shanghai University of Traditional Chinese Medicine
Updated on 15 September 2021

Summary

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).

Description

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.

Details
Condition Spondylosis
Treatment Sham acupuncture, Manual acupuncture, Digital Acupuncture Manipulation Therapeutic Instrument
Clinical Study IdentifierNCT04525651
SponsorShanghai University of Traditional Chinese Medicine
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

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
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