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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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, |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention. |
| Subjective Outcomes (Neck Disability Index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital | Hualien City | Hualien | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35422904 | Result | 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. | |
| 41322280 | 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. |
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Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include permission for public sharing of de-identified individual-level data. Data containing potentially identifiable information will be retained by the study investigators and institution in accordance with applicable regulations and ethical requirements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2020 | Jun 26, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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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.
|
| 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. |
|
We used self-reported Neck Disability Index scores to assess neck disability before and after treatment |
| The participants completed the Neck Disability Index questionnaire at baseline and on days 7 and 14 post-intervention. |
| 29198932 | 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. |
| 32125402 | 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. |
| 34980079 | 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. |