Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Cervical Spondylosis

Treatments: Other: Sham Acupuncture; Other: Manual Acupuncture; Device: Digital Acupuncture Manipulation Therapeutic Instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT04525651

lhzj20200810

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Digital Acupuncture Instrument Group

Experimental group

Description:

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.

Treatment:

Device: Digital Acupuncture Manipulation Therapeutic Instrument

Manual Acupuncture Group

Active Comparator group

Description:

Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument.

Treatment:

Other: Manual Acupuncture

Sham Acupuncture Group

Sham Comparator group

Description:

Patients in the SA group will receive non-invasive acupuncture to avoid de qi.

Treatment:

Other: Sham Acupuncture