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Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

Primary Purpose

Neck Pains

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

acupuncture

comprehensive treatment

About this trial

This is an interventional treatment trial for Neck Pains focused on measuring electroacupuncture therapy, neck pain, McGill Pain Questionnaire, Acupuncture Therapy, Electroacupuncture, Meridians

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

acupuncture

comprehensive treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

chronic neck pain-the Neck Pain Scale (NPQ)

the short-form McGill Pain Questionnaire

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

Secondary Outcome Measures

chronic neck pain-the Neck Pain Scale (NPQ)

the short-form McGill Pain Questionnaire

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

Full Information

NCT ID

NCT01674387

First Posted

August 16, 2012

Last Updated

August 10, 2021

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01674387

Brief Title

Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

Official Title

Lu's Acupuncture Protocol for Chronic Neck Pain

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

According to statistics, the incidence of chronic neck pain has significantly increased year by year, particularly tending to younger people, as social competition increase fiercely and the pace of people's daily work and life accelerate. Studying the effective treatment and prevention of chronic neck pain has obvious medical, social and economic significance. Purpose of this trial 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pains

Keywords

electroacupuncture therapy, neck pain, McGill Pain Questionnaire, Acupuncture Therapy, Electroacupuncture, Meridians

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acupuncture

Arm Type

Experimental

Arm Description

Arm Title

comprehensive treatment

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

acupuncture

Other Intervention Name(s)

electroacupuncture

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

comprehensive treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

chronic neck pain-the Neck Pain Scale (NPQ)

Time Frame

20 days(One course)

Title

the short-form McGill Pain Questionnaire

Time Frame

20 days(One course)

Title

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

Time Frame

20 days(one course)

Secondary Outcome Measure Information:

Title

chronic neck pain-the Neck Pain Scale (NPQ)

Time Frame

one month after a course.

Title

the short-form McGill Pain Questionnaire

Time Frame

one month after a course

Title

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

Time Frame

one months after a course

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Pei, MD

Organizational Affiliation

Longhua Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Qinhui Fu, MD

Organizational Affiliation

Longhua Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jia Yan, MM

Organizational Affiliation

Shanghai Univercity of TCM

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

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