Sinew Acupuncture for Neck Pain: Randomized Controlled Trial | NCT02834702

Studies
Sinew Acupuncture for Neck Pain: Randomized Controlled Trial

NCT02834702

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Nov 6, 2017Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Neck Pain

Interventions

Sinew acupuncture
Sham acupuncture

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Jul 13, 2016

First Submission Date that Met QC Criteria

Jul 14, 2016

First Posted Date

Jul 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2017

Last Update Posted Date

Nov 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sinew acupuncture	Experimental	Sinew acupuncture	Device: Sinew acupuncture
Sham acupuncture	Sham Comparator	Sham acupuncture	Device: Sham acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sinew acupuncture	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Haiyong Chen, PhD	Contact	39176413		haiyong@hku.hk

Name	Affiliation	Role
Haiyong Chen, PhD	The University of Hong Kong	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019547	Neck Pain
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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