Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

NCT ID: NCT01674387

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-12-31

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.

Conditions

Neck Pains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupuncture

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

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.

comprehensive treatment

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.

Group Type: OTHER

comprehensive treatment

Intervention Type: OTHER

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.

Interventions

acupuncture

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: DEVICE

comprehensive treatment

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.

Intervention Type: OTHER

Other Intervention Names

electroacupuncture

Eligibility Criteria

Inclusion Criteria

1. Age of a subject is older than 18 and is younger than 65.

2. With more than 3 months history of neck pain.

3. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

1. With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.

2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.

3. Patients have used drugs for preventing neck pain in the last four weeks.

4. Pregnant women or women in lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Longhua Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jian Pei,MD

MD,professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Pei, MD

Role: STUDY_DIRECTOR

Longhua Hospital

Qinhui Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Longhua Hospital

Jia Yan, MM

Role: PRINCIPAL_INVESTIGATOR

Shanghai Univercity of TCM

Other Identifiers

ZYSNXD-CCHPGC-JD-007

Identifier Type: OTHER

Identifier Source: secondary_id

64385700

Identifier Type: -

Identifier Source: org_study_id