NCT01674387

Brief Summary

Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

August 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 16, 2012

Last Update Submit

August 10, 2021

Conditions

Neck Pains

Keywords

electroacupuncture therapyneck painMcGill Pain QuestionnaireAcupuncture TherapyElectroacupunctureMeridians

Outcome Measures

Primary Outcomes (3)

  • chronic neck pain-the Neck Pain Scale (NPQ)

    20 days(One course)

  • the short-form McGill Pain Questionnaire

    20 days(One course)

  • the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).

    20 days(one course)

Secondary Outcomes (3)

  • chronic neck pain-the Neck Pain Scale (NPQ)

    one month after a course.

  • the short-form McGill Pain Questionnaire

    one month after a course

  • the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).

    one months after a course

Study Arms (2)

acupuncture

EXPERIMENTAL

56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral cervical Jiaji (EX-B2),and two trigger points.Bilateral Jianzhongshu (SI15) and Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.

Device: acupuncture

comprehensive treatment

OTHER

Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS(Transcutaneous Electrical Nerve Stimulation) therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.

Other: comprehensive treatment

Interventions

acupunctureDEVICE

56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral Jiaji (EX-B2) of cervical positive reaction plane (taking two pairs). Besides, bilateral Jianzhongshu (SI15) and bilateral Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.

Also known as: electroacupuncture
acupuncture
comprehensive treatmentOTHER

Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.

comprehensive treatment

Eligibility Criteria

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

You may qualify if:

  • Age of a subject is older than 18 and is younger than 65.
  • With more than 3 months history of neck pain.
  • Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

  • With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.
  • Psychotic，patients with allergic constitution or easily getting infected or bleeding.
  • Patients have used drugs for preventing neck pain in the last four weeks.
  • Pregnant women or women in lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Acupuncture TherapyElectroacupuncture

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Jian Pei, MD

    Longhua Hospital

    STUDY DIRECTOR

  • Qinhui Fu, MD

    Longhua Hospital

    PRINCIPAL INVESTIGATOR

  • Jia Yan, MM

    Shanghai Univercity of TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,professor

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 28, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2016

Last Updated

August 11, 2021

Record last verified: 2021-08