Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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).

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Detailed Description

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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

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Cervical Spondylosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital Acupuncture Instrument Group

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.

Group Type EXPERIMENTAL

Digital Acupuncture Manipulation Therapeutic Instrument

Intervention Type DEVICE

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.

Manual Acupuncture Group

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

Group Type ACTIVE_COMPARATOR

Manual Acupuncture

Intervention Type OTHER

Manual acupuncture to acheive de qi.

Sham Acupuncture Group

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

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

Sham acupuncture to avoid de qi.

Interventions

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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.

Intervention Type DEVICE

Manual Acupuncture

Manual acupuncture to acheive de qi.

Intervention Type OTHER

Sham Acupuncture

Sham acupuncture to avoid de qi.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes