Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Cervical Spondylosis Clinical Trial

Official title:

Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04525651
• Other study ID #: lhzj20200810
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Jian Pei, Doctor
• Phone: 00862164385700
• Email: longhuaacup[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Neck pain with the diagnosis of cervical spondylotic radiculopathy;

2. Aged between 18-70 years;

3. Have not participated in any drug clinical trials within the last month;

4. Voluntarily joining this study with informed consents

Exclusion Criteria:

1. A history of cervical spine trauma or have received cervical spine surgery;

2. Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;

3. Cervical spondylosis in urgent need of surgery;

4. Pregnant women and lactating women;

5. A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition

6. Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

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.
• Sham Acupuncture
Sham acupuncture to avoid de qi.

Locations

Country	Name	City	State
China	LongHua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)