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Recruiting NCT07741227

Electroacupuncture on Neck Muscle Stiffness in Chronic Neck Pain

No phase Interventional Chronic Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroacupuncture, Sham Electroacupuncture.
Who it may be relevant to
Registry conditions: Chronic Neck Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Immediate Effect of Electroacupuncture on Neck Muscle Stiffness in Individuals With Chronic Neck Pain

Overview

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. 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. 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. The primary objective is to evaluate immediate changes in the stiffness of the upper trapezius muscle, measured objectively via SWE (as Young's Modulus in kPa) before and immediately after the intervention. Secondary objectives include assessing immediate post-treatment changes in subjective pain and stiffness (Visual Analogue Scale), Pressure Pain Threshold (PPT), and active Cervical Range of Motion (CROM), alongside a 7-day post-intervention follow-up questionnaire on neck function.

Interventions

  • Procedure Electroacupuncture
    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 e
  • Procedure Sham Electroacupuncture
    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 adj

Primary outcome measures

  • Upper trapezius shear modulus [Time frame: Baseline (pre-intervention) and immediately post-intervention (within 15 minutes after needle removal, following a 5-minute rest period)]
Secondary outcome measures (6)
  • Pain intensity (VAS) [Time frame: Baseline and immediately post-intervention]
  • Pressure pain threshold - ipsilateral splenius capitis [Time frame: Baseline and immediately post-intervention]
  • Pressure pain threshold - contralateral upper trapezius [Time frame: Baseline and immediately post-intervention]
  • Pressure pain threshold - contralateral splenius capitis [Time frame: Baseline and immediately post-intervention]
  • Pressure pain threshold - bilateral tibialis anterior (remote) [Time frame: Baseline and immediately post-intervention]
  • Cervical range of motion [Time frame: Baseline and immediately post-intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07741227 · HSEARS20250926007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗