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Completed

NCT Number: NCT07681349

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

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.

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Key information

Conditions

Neck Pain Chronic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital

Hualien City, Hualien, 970, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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 Acupuncture

Other

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.

Primary outcomes

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

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

    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).

    • 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.

  2. Objective outcome (Muscle Tension Measurement)

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

    • 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).

  3. Objective outcome (Muscle Activation Onset Time)

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

    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.

Secondary outcomes

  1. Subjective Outcomes (Numerical Rating Scale)

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

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

  2. Subjective Outcomes (Neck Disability Index)

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

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

Sponsors and collaborators

Lead sponsor

Hualien Tzu Chi General Hospital

Other

Registry information

Official study title

Evaluation of the Effect of Acupuncture on 3 Dimensional Scapular Kinematics and Electromyographic Activity in Patients With Chronic Neck Discomfort

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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