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Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

This study is not yet open for participant recruitment.
Verified August 2012 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborator:
Longhua Hospital
Information provided by (Responsible Party):
Jian Pei,MD, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01674387
First received: August 16, 2012
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Neck Pains
 Device: acupuncture
Other: comprehensive treatment
Device: electro acupuncture
Device: traction
Device: low-frequency therapy.
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Lu's Acupuncture Protocol for Chronic Neck Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • chronic neck pain-the Neck Pain Scale (NPQ) [ Time Frame: 20 days(One course) ] [ Designated as safety issue: No ]
  • the short-form McGill Pain Questionnaire [ Time Frame: 20 days(One course) ] [ Designated as safety issue: No ]
  • the SF-36 Health Questionnaire combined with Neck Disability Index (NDI). [ Time Frame: 20 days(one course) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • chronic neck pain-the Neck Pain Scale (NPQ) [ Time Frame: one month after a course. ] [ Designated as safety issue: Yes ]
  • the short-form McGill Pain Questionnaire [ Time Frame: one month after a course ] [ Designated as safety issue: No ]
  • the SF-36 Health Questionnaire combined with Neck Disability Index (NDI). [ Time Frame: one months after a course ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
30 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.
 Device: acupuncture
30 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 Name: electroacupuncture
Device: electro acupuncture
Other Name: electro acupuncture
comprehensive treatment
Other 30 patients (the matched group) receive the comprehensive treatment, including traction and low-frequency therapy. Each treatment 15 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
 Other: comprehensive treatment
Other 30 patients (the matched group) receive the comprehensive treatment, including traction and low-frequency therapy. Each treatment 15 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
Other Name: comprehensive treatment
Device: traction Device: low-frequency therapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674387

Contacts
Contact: Jian Pei, MD 86-021-64385700 longhuaacup@yahoo.com.cn

Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Longhua Hospital
Investigators
Study Director: Pei Jian, MD Longhua Hospital
Principal Investigator: Qinhui Fu, MD Longhua Hospital
Principal Investigator: Jia Yan, MM Shanghai Univercity of TCM
  More Information

No publications provided

Responsible Party: Jian Pei,MD, MD,professor, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01674387     History of Changes
Other Study ID Numbers: 64385700, 201235-4
Study First Received: August 16, 2012
Last Updated: August 24, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai University of Traditional Chinese Medicine:
electroacupuncture therapy
neck pain
McGill Pain Questionnaire
 Acupuncture Therapy
Electroacupuncture
Meridians

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013