Clinical Trial: Sinew Acupuncture for Neck Pain: Randomized Controlled Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Sinew Acupuncture for Chronic Mechanical Neck Pain: a Randomized Assessor-blind Sham-controlled Trial

Brief Summary: The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).

Detailed Summary:

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.

Same as current

Current Secondary Outcome:

  • VAS [ Time Frame: week 1, 2 & 6 ]
  • Northwick Park Neck Pain Questionnaire (NPQ) [ Time Frame: week 1, 2, 3 & 6 ]
  • Short Form-36 (SF-36) [ Time Frame: week 1, 2, 3 & 6 ]


Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: July 13, 2016
Date Started: January 2017
Date Completion: June 2020
Last Updated: July 21, 2016
Last Verified: July 2016