Electroacupuncture on Neck Muscle Stiffness in Chronic Neck Pain

NCT07741227 | Recruiting

• 1 other identifier: HSEARS20250926007
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, single-blind, placebo-controlled clinical trial aims to investigate the immediate physiological effects of a single session of electroacupuncture (EA) on neck muscle stiffness in individuals with chronic neck pain. While acupuncture is a widely used complementary therapy for musculoskeletal pain, high-quality, objective evidence demonstrating its immediate effects on muscle biomechanics remains limited. This study will utilize Shear Wave Elastography (SWE)-a non-invasive, objective ultrasound-based technology-to measure these changes. Adult participants aged 18 to 65 with non-specific chronic neck pain (lasting ≥ 3 months) will be randomly allocated into one of two groups:

1. 1.True Electroacupuncture (EA) Group: Participants will receive a 20-minute session of active electroacupuncture with comfortable electrical stimulation at specific neck and tender points.
2. 2.Sham Acupuncture (Placebo) Group: Participants will receive a 20-minute session of non-penetrating sham acupuncture with a deactivated electroacupuncture device to ensure participant blinding.

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (1)

• Upper trapezius shear modulus

  Shear modulus (kPa) of the upper trapezius muscle measured by shear-wave elastography (SWE) at the midpoint between C7 spinous process and acromion on the treated side. Mean of 3 consecutive measurements. Young's modulus values divided by 3 to obtain shear modulus.

  Baseline (pre-intervention) and immediately post-intervention (within 15 minutes after needle removal, following a 5-minute rest period)

Secondary Outcomes (6)

• Pain intensity (VAS)

  Baseline and immediately post-intervention

• Pressure pain threshold - ipsilateral splenius capitis

  Baseline and immediately post-intervention

• Pressure pain threshold - contralateral upper trapezius

  Baseline and immediately post-intervention

• Pressure pain threshold - contralateral splenius capitis

  Baseline and immediately post-intervention

• Pressure pain threshold - bilateral tibialis anterior (remote)

  Baseline and immediately post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

A single 20-minute session of electroacupuncture administered by a registered Chinese Medicine Practitioner (\>10 years experience). Sterile single-use needles (0.25 mm × 25 mm or 0.30 mm × 40 mm) inserted at GB21, GB20, BL10, and local Ashi points on the affected upper trapezius to elicit de-qi. Needle pairs connected to a HANS-200A pulse generator delivering continuous asymmetric biphasic square wave at 2 Hz, pulse duration 200 μs, intensity titrated to maximum comfortable tolerance (checked every 5 min). Applied to the more painful/stiffer side; if bilateral and symmetrical, the dominant side is treated.

Procedure: Electroacupuncture

Sham Electroacupuncture

SHAM COMPARATOR

A single 20-minute session using validated Streitberger non-penetrating placebo needles at the same acupoints (GB21, GB20, BL10, Ashi). The blunt-tip needle retracts into the handle upon skin contact without penetrating the skin, secured with adhesive rings. The same HANS-200A device is connected but set to a deactivated mode (blinking lights and sounds active, no electrical current delivered). The practitioner follows an identical protocol and communication script as the EA group, including adjusting the intensity dial on the sham device.

Procedure: Sham Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

A single 20-minute session of electroacupuncture administered by a registered Chinese Medicine Practitioner (\>10 years experience). Sterile single-use needles (0.25 mm × 25 mm or 0.30 mm × 40 mm) inserted at GB21, GB20, BL10, and local Ashi points on the affected upper trapezius to elicit de-qi. Needle pairs connected to a HANS-200A pulse generator delivering continuous asymmetric biphasic square wave at 2 Hz, pulse duration 200 μs, intensity titrated to maximum comfortable tolerance (checked every 5 min). Applied to the more painful/stiffer side; if bilateral and symmetrical, the dominant side is treated.

Intervention

Sham Electroacupuncture PROCEDURE

A single 20-minute session using validated Streitberger non-penetrating placebo needles at the same acupoints (GB21, GB20, BL10, Ashi). The blunt-tip needle retracts into the handle upon skin contact without penetrating the skin, secured with adhesive rings. The same HANS-200A device is connected but set to a deactivated mode (blinking lights and sounds active, no electrical current delivered). The practitioner follows an identical protocol and communication script as the EA group, including adjusting the intensity dial on the sham device.

Sham Electroacupuncture

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years
• Chronic non-specific neck pain persisting for ≥3 months
• Average pain intensity ≥3 on a 0-10 Numeric Rating Scale over the past week
• Pain primarily located in the posterior cervical region, which may radiate to the upper trapezius muscles
• Able to provide informed consent and sufficient language proficiency to complete questionnaires

You may not qualify if:

• Specific pathological causes for neck pain (cervical radiculopathy or myelopathy, fracture, infection, tumour, systemic rheumatic disease)
• History of neck or shoulder surgery
• Contraindications to acupuncture (severe needle phobia, bleeding disorders, pregnancy)
• Received acupuncture or other physical therapy for neck pain within the past 6 months

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Hio Teng Leong

CONTACT

85227666707; annie-ht.leong@polyu.edu.hk

Study Design

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

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)