NCT04525651

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

August 11, 2020

Last Update Submit

September 1, 2021

Conditions

Cervical Spondylosis

Keywords

digital acupuncture manipulation therapeutic instrumentcervical spondylosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Neck Disability Index（NDI）

    Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)

  • short form 36-item questionnaire, SF-36

    Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)

Study Arms (3)

Digital Acupuncture Instrument Group

EXPERIMENTAL

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

Manual Acupuncture Group

ACTIVE COMPARATOR

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

Sham Acupuncture Group

SHAM COMPARATOR

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

Other: Sham Acupuncture

Interventions

Digital Acupuncture Manipulation Therapeutic InstrumentDEVICE

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.

Digital Acupuncture Instrument Group
Manual AcupunctureOTHER

Manual acupuncture to acheive de qi.

Manual Acupuncture Group
Sham AcupunctureOTHER

Sham acupuncture to avoid de qi.

Sham Acupuncture Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain with the diagnosis of cervical spondylotic radiculopathy;
  • Aged between 18-70 years;
  • Have not participated in any drug clinical trials within the last month;
  • Voluntarily joining this study with informed consents

You may not qualify if:

  • A history of cervical spine trauma or have received cervical spine surgery;
  • Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
  • Cervical spondylosis in urgent need of surgery;
  • Pregnant women and lactating women;
  • A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
  • Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LongHua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Jian Pei, Doctor

    Shanghai University of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Jian Pei, Doctor

CONTACT

00862164385700longhuaacup@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 25, 2020

Study Start

January 1, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

CN(1)