NCT04525651

Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Cervical Spondylosis

Interventions

Type	Name	Description
DEVICE	Digital Acupuncture Manipulation Therapeutic Instrument	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.
OTHER	Manual Acupuncture	Manual acupuncture to acheive de qi.
OTHER	Sham Acupuncture	Sham acupuncture to avoid de qi.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2020-08-25
• Last updated: 2021-09-10

Locations

1 site across 1 country: China