Sinew Acupuncture for Neck Pain: Randomized Controlled Trial

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).

Study Overview

• Status: Unknown
• Conditions: Neck Pain
• Intervention / Treatment: Device: Sinew acupuncture; Device: Sham acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyong Chen, PhD; Phone Number: 39176413; Email: haiyong@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) aged 18 years or above; (2) able to read and write Chinese; (3) the pain is located between the neck and shoulder regions and movement or palpation of the cervical region provokes the symptoms (18); (4) the pain has persisted for more than 3 months; (5) VAS (0 to 100 mm) pain score is ≥30 mm at baseline assessment; (6) no treatments (Chinese medicine, acupuncture, moxibustion, physiotherapies, medications, etc) intended for pain management have been received within the preceding two weeks.

Exclusion Criteria:

• (1) a history of fracture or surgery to the neck; (2) malignant tumor; (3) cervical congenital abnormality; (4) a severe psychiatric illness; (5) needle phobia; (6) acupuncture treatment in the preceding 3 months, and (7) other acupuncture contraindications as indicated in Hospital Authority Guideline on Safety in Acupuncture for Chinese Medicine Practitioners (Quality and Risk Sub-Committee, Hospital Authority, 2010).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinew acupuncture	Device: Sinew 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.
Sham Comparator: Sham acupuncture	Device: Sham acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	VAS at week 3	week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	VAS at week 1, 2 & 6	week 1, 2 & 6
Northwick Park Neck Pain Questionnaire (NPQ)	NPQ at week 1, 2, 3 & 6	week 1, 2, 3 & 6
Short Form-36 (SF-36)	SF-36 at week 1, 2, 3 & 6	week 1, 2, 3 & 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events at week 1, 2, 3 & 6	week 1, 2, 3 & 6

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain; neck pain; sinew acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: UHongKong-UW 15-456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No