Sinew Acupuncture for Neck Pain: Randomized Controlled Trial

NCT02834702 | Unknown

• 1 other identifier: UHongKong-UW 15-456
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neck Pain

Keywords

sinew acupuncture; neck pain; chronic pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  VAS at week 3

  week 3

Secondary Outcomes (3)

• VAS

  week 1, 2 & 6

• Northwick Park Neck Pain Questionnaire (NPQ)

  week 1, 2, 3 & 6

• Short Form-36 (SF-36)

  week 1, 2, 3 & 6

Other Outcomes (1)

• Adverse events

  week 1, 2, 3 & 6

Study Arms (2)

Sinew acupuncture

EXPERIMENTAL

Sinew acupuncture

Device: Sinew acupuncture

Sham acupuncture

SHAM COMPARATOR

Sham acupuncture

Device: Sham acupuncture

Interventions

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.

Sinew acupuncture

Sham acupuncture DEVICE

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.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haiyong Chen, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyong Chen, PhD

CONTACT

39176413; haiyong@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 15, 2016
• Study Start: September 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: November 6, 2017

Record last verified: 2017-10