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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hualien
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Hualien City、Hualien、台湾、970
- Hualien Tzu Chi Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective outcome (Range of Motion of the Cervical and Shoulder Joints)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Subjective Outcomes (Numerical Rating Scale)
時間枠：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)
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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