Neck Pain Clinical Trial
Official title:
A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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