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

NCT07681349 | Completed

• 1 other identifier: TCRD109-4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain Chronic

Keywords

chronic neck pain; sEMG; acupuncture; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  Baseline and immediately after completion of the intervention period

Secondary Outcomes (2)

• Subjective Outcomes (Numerical Rating Scale)

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

• Subjective Outcomes (Neck Disability Index)

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

Study Arms (2)

Acupuncture

EXPERIMENTAL

Participants in this group receive standardized acupuncture treatment administered by licensed acupuncturists. Sterile disposable needles are inserted at predefined acupuncture points according to the study protocol. one session of acupuncture treatment are delivered over the intervention period,

Other: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Participants in this group receive sham acupuncture designed to mimic the acupuncture procedure without providing specific therapeutic stimulation. The sham intervention is administered according to a standardized protocol and follows the same treatment schedule as the acupuncture group.

Other: Sham Acupuncture

Interventions

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.

Acupuncture

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hualien Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Hualien, 970, Taiwan

Location

Related Publications (5)

• Lin JG, Kotha P, Chen YH. Understandings of acupuncture application and mechanisms. Am J Transl Res. 2022 Mar 15;14(3):1469-1481. eCollection 2022.

  PMID: 35422904 RESULT

• Xie CR, Zhang ZY, Tao QF, Luo XD, Fu QX, Gao L, Wang T, Ouyang X, Yan QY, Sun MS, Wang X, Liang FR, Zheng H, Zhao L. Effectiveness of Acupuncture for Neck Pain: Systematic Review and Meta-analysis with Trial Sequential Analysis. J Pain Res. 2025 Nov 25;18:6297-6316. doi: 10.2147/JPR.S558059. eCollection 2025.

  PMID: 41322280 RESULT

• Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.

  PMID: 29198932 RESULT

• Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.

  PMID: 32125402 RESULT

• Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.

  PMID: 34980079 RESULT

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to treatment allocation and informed that they would receive one of two forms of acupuncture intervention. Outcome assessors responsible for collecting clinical, kinematic, and electromyographic data were blinded to group assignment. Data analysis was performed using coded group labels to maintain blinding until completion of the primary analyses. Acupuncturists delivering the interventions were not blinded because of the nature of the treatment procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Chinese Traumatology, Department of Chinese Medicine, Hualien Tzu Chi General Hospital

Model Details: Eligible participants are randomly allocated in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. Both groups receive treatment according to their assigned intervention throughout the study period. Outcomes, including scapular kinematics, electromyographic activity, pain intensity, and neck disability, are assessed at predefined time points. No crossover between groups is permitted.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 2, 2026
• Study Start: August 21, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 15, 2021
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)