The Hong Kong Polytechnic University
Hong Kong
Location status: Recruiting
NCT Number: NCT07741227
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline (pre-intervention) and immediately post-intervention (within 15 minutes after needle removal, following a 5-minute rest period)
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.
Time frame: Baseline and immediately post-intervention
Current neck pain intensity measured using a 100-mm Visual Analogue Scale, anchored "no pain" to "worst pain imaginable."
Time frame: Baseline and immediately post-intervention
PPT (kPa) at approximately 2 cm lateral to C4 spinous process on the treated side.
Time frame: Baseline and immediately post-intervention
PPT (kPa) at the UT midpoint on the untreated side.
Time frame: Baseline and immediately post-intervention
PPT (kPa) at approximately 2 cm lateral to C4 spinous process on the untreated side.
Time frame: Baseline and immediately post-intervention
PPT (kPa) over the belly of the tibialis anterior bilaterally, as an extra-cephalic remote reference site.
Time frame: Baseline and immediately post-intervention
Active cervical ROM in 6 directions (flexion, extension, left/right lateral flexion, left/right rotation) measured in degrees using a validated smartphone Clinometer application. Mean of 2 closest trials per direction.
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
The Immediate Effect of Electroacupuncture on Neck Muscle Stiffness in Individuals With Chronic Neck Pain
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