- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07681349
Evaluation of the Effect of Acupuncture on Objective Outcomes in Patients With Chronic Neck Discomfort
Evaluation of the Effect of Acupuncture on 3 Dimensional Scapular Kinematics and Electromyographic Activity 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hualien
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Hualien City, Hualien, Taiwan, 970
- Hualien Tzu Chi Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupuncture
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,
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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 Comparator: Sham Acupuncture
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective outcome (Range of Motion of the Cervical and Shoulder Joints)
Time Frame: Baseline and immediately after completion of the intervention period.
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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.
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|
Objective outcome (Muscle Tension Measurement)
Time Frame: Baseline and immediately after completion of the intervention period.
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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).
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Baseline and immediately after completion of the intervention period.
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Objective outcome (Muscle Activation Onset Time)
Time Frame: Baseline and immediately after completion of the intervention period
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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.
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Baseline and immediately after completion of the intervention period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Outcomes (Numerical Rating Scale)
Time Frame: The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention.
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We used self-reported Numerical Rating Scale scores (from 0 to 10)to assess pain intensity of neck before and after treatment.
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The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention.
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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.
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We used self-reported Neck Disability Index scores to assess neck disability before and after treatment
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The participants completed the Neck Disability Index questionnaire at baseline and on days 7 and 14 post-intervention.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCRD109-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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