An interventional study of Sinew acupuncture and Sham acupuncture in Neck Pain, sponsored by The University of Hong Kong. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's planned enrollment of 130 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sinew acupuncture
Device: Sinew acupuncture
Sham acupuncture
Device: Sham acupuncture
The subject is asked to be on sitting posture. The skin around the needling points is disinfected with a 75% alcohol swap. A tube-guided, sterilized, disposal needle is then inserted (at a small angle to the skin) into the acupoint at 0.5-1 cun (depending on point location and body size of the subject). No needle sensation (deqi sensation) is required. A piece of surgical adhesive tape will be applied to the needle immediately after insertion.
The procedure in the sham acupuncture group will be as similar to that of the acupuncture group as possible. In the sham acupuncture group, however, a mock plastic needle guiding tube is tapped on the surface of each acupoint (Ashi point and traditional acupoints) to produce some discernible sensation. A piece of adhesive tape is immediately applied to fix the needle on the dermal surface tapped, without needle insertion. In addition, a plastic tube-guided needle is superficially inserted at the sham point at less than 5mm in depth.
Visual Analog Scale (VAS)
VAS at week 3
Time frame: week 3
VAS
VAS at week 1, 2 \& 6
Time frame: week 1, 2 & 6
Northwick Park Neck Pain Questionnaire (NPQ)
NPQ at week 1, 2, 3 \& 6
Time frame: week 1, 2, 3 & 6
Short Form-36 (SF-36)
SF-36 at week 1, 2, 3 \& 6
Time frame: week 1, 2, 3 & 6
Adverse events
Adverse events at week 1, 2, 3 \& 6
Time frame: week 1, 2, 3 & 6
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong