NCT04539184

Brief Summary

The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

August 26, 2020

Last Update Submit

November 18, 2021

Conditions

Acute Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale(VAS) on movement

    Minimum 0, Maximum 100. Higher values represent a worse outcome

    Change from baseline VAS at 3 weeks

Secondary Outcomes (18)

  • Visual Analogue Scale (VAS) on movement

    Baseline(Week 1), Week 2, 3, 8

  • Visual Analogue Scale (VAS) at rest

    Baseline(Week 1), Week 2, 3, 8

  • Numeric Rating Scale (NRS) on movement

    Baseline(Week 1), Week 2, 3, 8

  • Numeric Rating Scale (NRS) at rest

    Baseline(Week 1), Week 2, 3, 8

  • Vernon-Mior Neck Disability Index (NDI)

    Baseline(Week 1), Week 2, 3, 8

  • +13 more secondary outcomes

Study Arms (2)

Motion Style Acupuncture treatment

EXPERIMENTAL

Motion Style Acupuncture treatment (2-3 times/week, 2 weeks)

Other: Motion Style Acupuncture Treatment (MSAT)

Acupuncture treatment

ACTIVE COMPARATOR

Acupuncture treatment (2-3 times/week, 2 weeks)

Other: Acupuncture

Interventions

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.

Motion Style Acupuncture treatment
AcupunctureOTHER

General acupuncture

Acupuncture treatment

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 41572363DERIVED

  • Kim 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.

    PMID: 33126334DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • In-Hyuk Ha, Dr.

    Jaseng Medical Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 4, 2020

Study Start

September 10, 2020

Primary Completion

November 18, 2021

Study Completion

November 18, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)