Acute Neck PainNCT04539184
The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial
A study testing Motion Style Acupuncture Treatment (MSAT) and Acupuncture in people with Acute Neck Pain, run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial summary
The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Acute Neck Pain
- What is being tested?
- Motion Style Acupuncture Treatment (MSAT) and Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 10 Sep 2020to 18 Nov 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain onset or worsen within one month
- VAS of neck pain on movement or at rest of 5 or higher
- Age between 19 and 70 years old
- Participants who wrote a informed consent
Who cannot join
- Participants who diagnosed with the serious disease that can cause pain (e.g. Migration of cancer reaching to spine, fracture of spine, dislocation of spine)
- Progressive neurologic deficits or severe neurologic deficits
- Participants who diagnosed with a soft tissue disease that can cause pain (Cancer, fibromyalgia, RA, or goat)
- Chronic disease (e.g. Cardiovascular disease, kidney disease, dementia, diabetic neuropathy, or epilepsy)
- Participants taking steroids, immunosuppressants, or psychotropic medication
- Participants who could be inadequate or unsafe at acupuncture (e.g. Hemorrhagic disease, severe diabetes or taking anticoagulant drug)
Show all 13Show fewer
- Participants who took NSAIDs or acupuncture within 3 days
- Participants who had undergone cervical surgery within 3 months
- Participants who had a traffic accident within a month
- Pregnant or women who planned to conceive
- Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial within 6 months from enrollment
- Participants who can not write informed consent
- Participants who is difficult to participate in the trial according to investigator's decision
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.
Read the detailed description
This is a multi-center, randomized, controlled, comparative effectiveness clinical trial for acute neck pain. Motion style acupuncture requires a part of the patient's body to move passively or actively while acupuncture needles are retained.
- Conditions
- Acute Neck Pain
- Being tested
- Motion Style Acupuncture Treatment (MSAT), Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion Style Acupuncture Treatment (MSAT)Other
MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.
AcupunctureOther
General acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Motion Style Acupuncture treatment | Experimental | Motion Style Acupuncture treatment (2-3 times/week, 2 weeks) Receives: Other: Motion Style Acupuncture Treatment (MSAT) |
| Acupuncture treatment | Active comparator | Acupuncture treatment (2-3 times/week, 2 weeks) Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale(VAS) on movement
Minimum 0, Maximum 100. Higher values represent a worse outcome
Measured: Change from baseline VAS at 3 weeks
Secondary outcomes (18)
Visual Analogue Scale (VAS) on movement
Minimum 0, Maximum 100. Higher values represent a worse outcome
Measured: Baseline(Week 1), Week 2, 3, 8
Visual Analogue Scale (VAS) at rest
Minimum 0, Maximum 100. Higher values represent a worse outcome
Measured: Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) on movement
Minimum 0, Maximum 10. Higher values represent a worse outcome
Measured: Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) at rest
Minimum 0, Maximum 10. Higher values represent a worse outcome
Measured: Baseline(Week 1), Week 2, 3, 8
Vernon-Mior Neck Disability Index (NDI)
Functional disability questionnaire
Measured: Baseline(Week 1), Week 2, 3, 8
Northwick Park Neck Pain Questionnaire (NPQ)
Functional disability questionnaire and Pain questionnaire
Measured: Baseline(Week 1), Week 2, 3, 8
Patient Global Impression of Change (PGIC)
Global, patient-reported outcome, Minimum 1, Maximum 7, Higher values represent a better outcome
Measured: Week 3, 8
Range of movement (ROM) of flexion
Range of movement of flexion
Measured: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of extension
Range of movement of extension
Measured: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt rotation
Range of movement of Right rotation
Measured: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Lt rotation
Range of movement of Left rotation
Measured: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Lt lateroflexion
Range of movement of Left lateroflexion
Measured: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt lateroflexion
Range of movement of Right lateroflexion
Measured: Baseline(Week 1), Week 2, 3, 8
EQ-5D-5L
Health-related quality of life questionnaire
Measured: Baseline(Week 1), 3, 8
12-item Short-Form Health Survey (SF-12)
Health-related quality of life questionnaire
Measured: Baseline(Week 1), 3, 8
EuroQol Visual Analogue Scale (EQ-VAS)
Health-related quality of life questionnaire
Measured: Baseline(Week 1), 3, 8
Adverse events
Safety outcome
Measured: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
Drug Consumption
Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments
Measured: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start10 Sep 2020
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Neck PainStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Dr., Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539184
- Sponsor's protocol ID
- JS-CT-2020-08
- Status last verified
- Nov 2021
- First submitted
- 26 Aug 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee YJ, Kim D, Park KS, Kim S, Seo JY, Cho HW, Heo I, Shin WC, Cho JH, Kim JH, Seo BK, Ha IH. Effectiveness and safety of motion style acupuncture treatment for acute neck pain: a multicenter randomized controlled trial. Chin Med. 2026 Jan 23;21(1):49. doi: 10.1186/s13020-026-01332-0.
PubMed 41572363Kim D, Lee YJ, Park KS, Kim S, Seo JY, Cho HW, Ha IH. The effectiveness and cost-effectiveness of motion style acupuncture treatment (MSAT) for acute neck pain: A multi-center randomized controlled trial. Medicine (Baltimore). 2020 Oct 30;99(44):e22871. doi: 10.1097/MD.0000000000022871.
PubMed 33126334
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04539184
- Acronym / sponsor ID
- JS-CT-2020-08
- Conditions
- Acute Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 4 Sep 2020 (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 investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.
Detailed description
This is a multi-center, randomized, controlled, comparative effectiveness clinical trial for acute neck pain. Motion style acupuncture requires a part of the patient's body to move passively or actively while acupuncture needles are retained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motion Style Acupuncture treatment | Experimental | Other: Motion Style Acupuncture Treatment (MSAT)Motion Style Acupuncture treatment (2-3 times/week, 2 weeks) |
| Acupuncture treatment | Active comparator | Other: AcupunctureAcupuncture treatment (2-3 times/week, 2 weeks) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neck pain onset or worsen within one month
- VAS of neck pain on movement or at rest of 5 or higher
- Age between 19 and 70 years old
- Participants who wrote a informed consent
Key exclusion criteria (13 listed)
- Participants who diagnosed with the serious disease that can cause pain (e.g. Migration of cancer reaching to spine, fracture of spine, dislocation of spine)
- Progressive neurologic deficits or severe neurologic deficits
- Participants who diagnosed with a soft tissue disease that can cause pain (Cancer, fibromyalgia, RA, or goat)
- Chronic disease (e.g. Cardiovascular disease, kidney disease, dementia, diabetic neuropathy, or epilepsy)
- Participants taking steroids, immunosuppressants, or psychotropic medication
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 |
|---|---|---|
| Motion Style Acupuncture Treatment (MSAT)MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained. | Other | Motion Style Acupuncture treatment |
| AcupunctureGeneral acupuncture | Other | Acupuncture treatment |
Primary outcome
Visual Analogue Scale(VAS) on movement
Time frame: Change from baseline VAS at 3 weeks
Minimum 0, Maximum 100. Higher values represent a worse outcome
18 secondary outcomes
Visual Analogue Scale (VAS) on movement
Time frame: Baseline(Week 1), Week 2, 3, 8
Visual Analogue Scale (VAS) at rest
Time frame: Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) on movement
Time frame: Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) at rest
Time frame: Baseline(Week 1), Week 2, 3, 8
Vernon-Mior Neck Disability Index (NDI)
Time frame: Baseline(Week 1), Week 2, 3, 8
Northwick Park Neck Pain Questionnaire (NPQ)
Time frame: Baseline(Week 1), Week 2, 3, 8
Patient Global Impression of Change (PGIC)
Time frame: Week 3, 8
Range of movement (ROM) of flexion
Time frame: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of extension
Time frame: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt rotation
Time frame: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Lt rotation
Time frame: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Lt lateroflexion
Time frame: Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt lateroflexion
Time frame: Baseline(Week 1), Week 2, 3, 8
EQ-5D-5L
Time frame: Baseline(Week 1), 3, 8
12-item Short-Form Health Survey (SF-12)
Time frame: Baseline(Week 1), 3, 8
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: Baseline(Week 1), 3, 8
Adverse events
Time frame: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
Drug Consumption
Time frame: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
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 19 Nov 2021.
- Derived from this study: PubMed 41572363Lee YJ, Kim D, Park KS, Kim S, Seo JY, Cho HW, Heo I, Shin WC, Cho JH, Kim JH, Seo BK, Ha IH. Effectiveness and safety of motion style acupuncture treatment for acute neck pain: a multicenter randomized controlled trial. Chin Med. 2026 Jan 23;21(1):49. doi: 10.1186/s13020-026-01332-0.
- Derived from this study: PubMed 33126334Kim D, Lee YJ, Park KS, Kim S, Seo JY, Cho HW, Ha IH. The effectiveness and cost-effectiveness of motion style acupuncture treatment (MSAT) for acute neck pain: A multi-center randomized controlled trial. Medicine (Baltimore). 2020 Oct 30;99(44):e22871. doi: 10.1097/MD.0000000000022871.
- Individual participant dataSharing planned: No
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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.
In-Hyuk Ha, Dr. principal investigator
Jaseng Medical Foundation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion Style Acupuncture Treatment (MSAT) and Acupuncture in people with Acute Neck Pain, run by Jaseng Medical Foundation at 4 sites in South Korea.
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 4 inclusion and 13 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. 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?
Visual Analogue Scale(VAS) on movement (time frame: Change from baseline VAS at 3 weeks). 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 NCT04539184, which also lists 2 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 19 Nov 2021.