Neck Pain Clinical Trial
Official title:
Sinew Acupuncture for Chronic Mechanical Neck Pain: a Randomized Assessor-blind Sham-controlled Trial
The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).
Objectives:
Sinew acupuncture is a superficial needling technique with the advantage of minimal pain,
feasible manipulation, and no apparent adverse effects. The proposal aims to examine the
efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).
Hypothesis to be tested:
Sinew acupuncture can reduce pain intensity, and improve neck pain disability and
health-related quality of life without significant side effects for CMNP subjects compared to
a sham acupuncture treatment.
Design:
A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial
Participants:
Subjects (N=130) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1
ratio).
Study instrument:
Visual Analog Scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ) and Short Form-36
(SF-36)
Intervention:
Sinew acupuncture group will receive five sessions of needling in two weeks. Sham group will
receive the non-invasive treatment with the same procedures. All subjects are followed up for
4 weeks.
Main outcome measures:
VAS for neck pain intensity at week 3 serves as the primary outcome. VAS at other time
points, NPQ score and SF-36 at week 1, 2, 3, and 6, and adverse events are analyzed as the
secondary outcomes.
Data analysis:
Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model
analysis will be used to measure primary and secondary outcomes respectively.
Expected results:
Five sessions of sinew acupuncture treatment can significantly reduce neck pain intensity,
and improve neck pain disability and quality of life without obvious side effects.
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