Evaluation of the Effect of Acupuncture on Objective Outcomes in Patients With Chronic Neck Discomfort

Hualien Tzu Chi General Hospital50 enrolled

Overview

The goal of this clinical trial is to determine whether acupuncture can improve neck pain and shoulder movement in people with chronic neck pain. Researchers will compare acupuncture with sham acupuncture (a procedure designed to resemble acupuncture without therapeutic effects) to determine whether acupuncture provides specific benefits. Participants will be randomly assigned to receive either acupuncture or sham acupuncture. They will attend 1 treatment session and undergo assessments of neck and shoulder movement, muscle activity, pain intensity, and neck-related disability before and after treatment. Researchers will also monitor any adverse events associated with treatment.

The goal of this clinical trial is to learn whether acupuncture can improve neck and shoulder function in patients with chronic neck pain. It will also evaluate the effects of acupuncture on scapular movement, muscle activity, pain intensity, and neck-related disability. The main questions it aims to answer are: Does acupuncture improve muscle activation onset time in patients with chronic neck pain? Does acupuncture change electromyographic activity of the neck and shoulder muscles? Does acupuncture reduce pain intensity and neck-related disability? Researchers will compare real acupuncture with sham acupuncture to determine whether the observed effects are specifically related to acupuncture treatment. Participants will: Be randomly assigned to receive either real acupuncture or sham acupuncture Receive one treatment session over the study intervention period. Undergo assessments of muscle activation onset time and electromyographic activity before and after treatment Complete questionnaires evaluating pain intensity, neck disability, and related symptoms Attend follow-up assessments and report any adverse events during the study period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Interventions

AcupunctureOTHER

Participants receive standardized acupuncture treatment administered by licensed acupuncturists. Disposable sterile needles are inserted at predefined acupuncture points selected for chronic neck pain management. Manual needle stimulation is applied to elicit deqi sensation, and needles are retained for approximately 20-30 minutes per session. Treatments are delivered according to a standardized protocol throughout the study period.

Sham AcupunctureOTHER

Participants receive sham acupuncture using non-penetrating placebo needles that simulate needle insertion without skin penetration. The sham procedure is performed at predefined non-acupuncture locations and follows the same treatment frequency, duration, and clinical procedures as the acupuncture group. The intervention is designed to maintain participant blinding while minimizing specific physiological effects associated with acupuncture.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age between 18 and 65 years; * presence of neck discomfort for at least 3 months; and * baseline neck disability index(NDI) score between 5 and 24, indicating mild to moderate disability, and baseline Numerical Rating Scale (NRS) score between 1 and 6 for pain intensity. Exclusion Criteria: * scored \>24 on the NDI, indicating severe disability; * had a history of neck, shoulder, or upper limb surgery or major trauma; * had restricted shoulder joint ROM, joint instability, or shoulder pain during movement; * had taken analgesics, muscle relaxants, anti-inflammatory agents, or traditional Chinese or Western medicine 3 days prior to study initiation; * had received acupuncture, massage, cupping, or other manual therapies within 1 week prior to the intervention; and/or * were pregnant.

Outcomes

Primary Outcomes

Objective outcome (Range of Motion of the Cervical and Shoulder Joints)

The primary outcome variables were the ROM of the cervical and shoulder joints, muscle tension, and muscle activation onset time measured using surface electromyography (sEMG). 1\. Range of Motion (ROM) of the Cervical and Shoulder Joints Cervical ROM (flexion, extension, and bilateral side-bending) and shoulder ROM (flexion, external rotation and internal rotation on the affected side) were measured using a standard universal goniometer.

Time frame: Baseline and immediately after completion of the intervention period.

Objective outcome (Muscle Tension Measurement)

2\. Muscle Tension Measurement Passive mechanical properties of the muscles (upper trapezius \[UT\], lower trapezius \[LT\], and middle deltoid \[MiD\]) were evaluated using a handheld digital myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia).

Time frame: Baseline and immediately after completion of the intervention period.

Objective outcome (Muscle Activation Onset Time)

Muscle activation onset time of the upper trapezius \[UT\], lower trapezius \[LT\], and middle deltoid \[MiD\], and serratus anterior (SA) during shoulder scaption was evaluated via Surface Electromyography (sEMG) (Noraxon USA Inc, Scottsdale, AZ). All procedures followed the sEMG for the Non-Invasive Assessment of Muscles recommendations.

Time frame: Baseline and immediately after completion of the intervention period

Secondary Outcomes

Subjective Outcomes (Numerical Rating Scale)

We used self-reported Numerical Rating Scale scores (from 0 to 10)to assess pain intensity of neck before and after treatment.

Time frame: The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention.

Subjective Outcomes (Neck Disability Index)

We used self-reported Neck Disability Index scores to assess neck disability before and after treatment

Time frame: The participants completed the Neck Disability Index questionnaire at baseline and on days 7 and 14 post-intervention.