Electroacupuncture for Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826215
Recruitment Status : Unknown
Verified January 2009 by Hong Kong Baptist University.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
The Hong Kong Polytechnic University
Information provided by:
Hong Kong Baptist University

Brief Summary:

Objective: The primary objective of this study is to evaluate the long-term efficacy of electroacupuncture for chronic neck pain. The secondary objective is to document any possible side effects of acupuncture.

Design and Subjects: Prospective, randomised controlled trial comparing the outcomes of treatment and placebo interventions. Subjects are 200 adult patients with chronic mechanical neck pain.

Setting: Outpatient clinics.

Interventions: Patients will be randomly allocated to one of the two groups receiving either: electroacupuncture (real treatment) or placebo (sham laser acupuncture). Each treatment will last for 45 minutes. Each patient will receive a total of nine treatments (three times per week for three weeks).

Main outcome measures:

Primary outcome measures: Neck pain disability index (Northwick Park Neck Pain Questionnaire).

Secondary outcome measures: Maximum pain related to motion on visual analogue scale. Quality of life (SF-36). Use of medication. Sick leave because of neck pain. Treatment-related adverse effects, such as pain, skin irritation, bleeding and dizziness, will also be assessed.

Assessments will be made before treatment, one month, three months and six months after the treatment course. The credibility of placebo treatment will also be assessed.

Expected results: We expect that patients in the treatment group will have significant improvements on primary and secondary outcome measures, when compared with patients in the inert placebo group.

Conclusion: This study will provide credible evidence regarding whether electroacupuncture is effective in reducing chronic neck pain. Patients, healthcare professionals, and government policy makers can make use of this information to improve clinical outcomes and reduce costs

Condition or disease Intervention/treatment Phase
Neck Pain Device: electroacupuncture Device: Sham laser acupuncture Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain
Study Start Date : March 2007
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Electroacupuncture treatment
Device: electroacupuncture
Nine sections of 45 minutes electroacupuncture treatment in three weeks

Sham Comparator: 2
Sham laser acupuncture
Device: Sham laser acupuncture
Sham laser acupuncture

Primary Outcome Measures :
  1. Change in neck pain specific disability index as measured by the Northwick Park Neck Pain Questionnaire (NPQ). [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. i) Change in maximum pain related to motion, regardless the direction of movement. ii) Quality of life as assessed by SF-36 health survey. iii) Use of medication because of neck pain iv) Sick leave because of neck pain. [ Time Frame: 6 months ]
  2. Adverse effects. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult male or female subjects age above 18 with mechanical neck pain for over three months.

Exclusion Criteria:

  • Patients who have received acupuncture treatment for any purpose in the last 6 months.
  • Patients who will be unlikely to attend all treatment sessions.
  • Patients with systemic diseases, such as diabetes or cardiovascular disorder.
  • Patients with a history of traumatic injury of the neck or upper back from T1-T6, precious fracture or surgery to the neck, neurological deficits (e.g., muscle weakness or changes in spinal reflex jerks), a history of malignancy, congenital abnormality of the spine, or systemic bone and joint disorders (e.g., RA).
  • Patients who are seeking compensation for neck-related condition.
  • Patients who have needle phobia.
  • Pregnant and breast feeding women.

Responsible Party: Dr. Shi Ping Zhang, School of Chinese Medicine, Hong Kong Baptist Universtiy Identifier: NCT00826215     History of Changes
Other Study ID Numbers: 04060191
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by Hong Kong Baptist University:
neck pain
chronic mechanical neck pain

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