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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00826215
Study type Interventional
Source Hong Kong Baptist University
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 2007
Completion date February 2009

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