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Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT01674387
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : May 6, 2014
Sponsor:
Collaborator:
Longhua Hospital
Information provided by (Responsible Party):
Jian Pei,MD, Shanghai University of Traditional Chinese Medicine

August 16, 2012
August 28, 2012
May 6, 2014
August 2012
August 2013   (Final data collection date for primary outcome measure)
  • chronic neck pain-the Neck Pain Scale (NPQ) [ Time Frame: 20 days(One course) ]
  • the short-form McGill Pain Questionnaire [ Time Frame: 20 days(One course) ]
  • the SF-36 Health Questionnaire combined with Neck Disability Index (NDI). [ Time Frame: 20 days(one course) ]
Same as current
Complete list of historical versions of study NCT01674387 on ClinicalTrials.gov Archive Site
  • chronic neck pain-the Neck Pain Scale (NPQ) [ Time Frame: one month after a course. ]
  • the short-form McGill Pain Questionnaire [ Time Frame: one month after a course ]
  • the SF-36 Health Questionnaire combined with Neck Disability Index (NDI). [ Time Frame: one months after a course ]
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Neck Pains
  • 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
  • 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.
  • Device: electro acupuncture
  • Device: traction
  • Device: low-frequency therapy.
  • 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.
    Interventions:
    • Device: acupuncture
    • Device: 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.
    Interventions:
    • Other: comprehensive treatment
    • Device: traction
    • Device: low-frequency therapy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
January 2014
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01674387
64385700
201235-4
Yes
Not Provided
Not Provided
Jian Pei,MD, Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Longhua Hospital
Study Director: Jian Pei, MD Longhua Hospital
Principal Investigator: Qinhui Fu, MD Longhua Hospital
Principal Investigator: Jia Yan, MM Shanghai Univercity of TCM
Shanghai University of Traditional Chinese Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP