Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Not Applicable

• Conditions: Cervical Spondylosis
• Interventions: Other: Sham Acupuncture; Device: Digital Acupuncture Manipulation Therapeutic Instrument; Other: Manual Acupuncture

• Registration Number: NCT04525651
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-25
• Study Start: 2021-01-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-10
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupuncture Group	Sham Acupuncture	Patients in the SA group will receive non-invasive acupuncture to avoid de qi.
Digital Acupuncture Instrument Group	Digital Acupuncture Manipulation Therapeutic Instrument	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.
Manual Acupuncture Group	Manual Acupuncture	Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument.

Primary Outcome Measures

Name	Time	Method
Visual Analogue scale（VAS）	Change from baseline VAS at 8weeks	A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index（NDI）	Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)	A scale that helps a patient to quantify neck disability.
short form 36-item questionnaire, SF-36	Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)	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.

Trial Locations

Locations (1)

LongHua Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China