Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

Lu's Acupuncture Protocol for Chronic Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pains
• Intervention / Treatment: Device: acupuncture; Other: comprehensive treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.; Other Names: electroacupuncture
OTHER: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Longhua Hospital
• Investigators: Study Director: Jian Pei, MD, Longhua Hospital; Principal Investigator: Qinhui Fu, MD, Longhua Hospital; Principal Investigator: Jia Yan, MM, Shanghai Univercity of TCM

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: neck pain; Electroacupuncture; Acupuncture Therapy; electroacupuncture therapy; McGill Pain Questionnaire; Meridians
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 64385700; ZYSNXD-CCHPGC-JD-007 (OTHER: Shanghai Municipal Commission of Health and Family Planning)