Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

September 1, 2021 updated by: Shanghai University of Traditional Chinese Medicine
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Other: Manual Acupuncture
Manual acupuncture to acheive de qi.
Sham Comparator: Sham Acupuncture Group
Patients in the SA group will receive non-invasive acupuncture to avoid de qi.
Other: Sham Acupuncture
Sham acupuncture to avoid de qi.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue scale（VAS）
Time Frame: Change from baseline VAS at 4weeks
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
Visual Analogue scale（VAS）
Time Frame: 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.
Change from baseline VAS at 8weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Investigators

  • Study Chair: Jian Pei, Doctor, Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lhzj20200810

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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