Neck Pain ChronicNCT07681349
Evaluation of the Effect of Acupuncture on Objective Outcomes in Patients With Chronic Neck Discomfort
A study testing Acupuncture in people with Neck Pain Chronic, run by Hualien Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain Chronic
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2020to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain Chronic
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- chronic neck pain, sEMG, acupuncture, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
- 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.
Measured: Baseline and immediately after completion of the intervention period.
Objective outcome (Muscle Tension Measurement)
- 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).
Measured: 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.
Measured: Baseline and immediately after completion of the intervention period
Secondary outcomes (2)
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.
Measured: The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention.
Subjective Outcomes (Neck Disability Index)
We used self-reported Neck Disability Index scores to assess neck disability before and after treatment
Measured: The participants completed the Neck Disability Index questionnaire at baseline and on days 7 and 14 post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start21 Aug 2020
- Primary completion31 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualien Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsuan-Shu Shen, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681349
- Sponsor's protocol ID
- TCRD109-4
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35422904Xie 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.
PubMed 41322280Vickers 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.
PubMed 29198932Dieleman 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.
PubMed 32125402Kazeminasab 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.
PubMed 34980079
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Acupuncture on 3 Dimensional Scapular Kinematics and Electromyographic Activity in Patients With Chronic Neck Discomfort
- ClinicalTrials.gov ID
- NCT07681349
- Acronym / sponsor ID
- TCRD109-4
- Conditions
- Neck Pain Chronic
- Keywords
- chronic neck pain, sEMG, acupuncture, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hualien Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureParticipants 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, |
| Sham Acupuncture | Sham comparator | Other: Sham AcupunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureParticipants 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. | Other | Acupuncture |
| Sham AcupunctureParticipants 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. | Other | Sham Acupuncture |
Primary outcome
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). 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.
Objective outcome (Muscle Tension Measurement)
Time frame: Baseline and immediately after completion of the intervention period.
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).
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.
2 secondary outcomes
Subjective Outcomes (Numerical Rating Scale)
Time frame: The participants completed the Numerical Rating Scale at baseline and on days 7 and 14 post-intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Results publication: PubMed 35422904Lin JG, Kotha P, Chen YH. Understandings of acupuncture application and mechanisms. Am J Transl Res. 2022 Mar 15;14(3):1469-1481. eCollection 2022.
- Results publication: PubMed 41322280Xie 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.
- Results publication: PubMed 29198932Vickers 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.
- Results publication: PubMed 32125402Dieleman 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.
- Results publication: PubMed 34980079Kazeminasab 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Neck Pain Chronic
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Neck Pain Chronic, run by Hualien Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective outcome (Range of Motion of the Cervical and Shoulder Joints) (time frame: Baseline and immediately after completion of the intervention period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681349, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.