Electroacupuncture on Neck Muscle Stiffness in Chronic Neck Pain
ConditionChronic Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Electroacupuncture
Procedure/SurgeryA 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.
Sham Electroacupuncture
Procedure/SurgeryA 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-intervention) and immediately post-intervention (within 15 minutes after needle removal, following a 5-minute rest period)Secondary outcomes
1
Pain intensity (VAS)
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-intervention2
Pressure pain threshold - ipsilateral splenius capitis
PPT (kPa) at approximately 2 cm lateral to C4 spinous process on the treated side.
Time frame
Baseline and immediately post-intervention3
Pressure pain threshold - contralateral upper trapezius
PPT (kPa) at the UT midpoint on the untreated side.
Time frame
Baseline and immediately post-intervention4
Pressure pain threshold - contralateral splenius capitis
PPT (kPa) at approximately 2 cm lateral to C4 spinous process on the untreated side.
Time frame
Baseline and immediately post-interventionSponsors and contacts
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Source ClinicalTrials.gov