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Sponsors and Collaborators: |
Hong Kong Baptist University The Hong Kong Polytechnic University |
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Information provided by: | Hong Kong Baptist University |
ClinicalTrials.gov Identifier: | NCT00826215 |
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 | Intervention | Phase |
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Neck Pain |
Device: electroacupuncture Device: Sham laser acupuncture |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain |
Estimated Enrollment: | 200 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Electroacupuncture treatment
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Device: electroacupuncture
Nine sections of 45 minutes electroacupuncture treatment in three weeks
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2: Sham Comparator
Sham laser acupuncture
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Device: Sham laser acupuncture
Sham laser acupuncture
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | School of Chinese Medicine, Hong Kong Baptist Universtiy ( Dr. Shi Ping Zhang ) |
Study ID Numbers: | 04060191 |
Study First Received: | January 21, 2009 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00826215 History of Changes |
Health Authority: | Hong Kong: Committee on the use of human & animal subjects in teaching and research HKBU |
mechanical neck pain chronic acupuncture chronic mechanical neck pain |
Signs and Symptoms Neck Pain Neurologic Manifestations Pain |
Signs and Symptoms Nervous System Diseases Neck Pain Neurologic Manifestations Pain |