The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial

November 18, 2021 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation
The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Haeundae Jaseng Hospital of Korean Medicine
      • Daejeon, Korea, Republic of, 35262
        • Daejeon Jaseng Hospital of Korean Medicine
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
        • Jaseng Hospital of Korean Medicine
    • Gyeonggi Province
      • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
        • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Motion Style Acupuncture treatment
Motion Style Acupuncture treatment (2-3 times/week, 2 weeks)
Other: Motion Style Acupuncture Treatment (MSAT)
MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.
ACTIVE_COMPARATOR: Acupuncture treatment
Acupuncture treatment (2-3 times/week, 2 weeks)
Other: Acupuncture
General acupuncture

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline VAS at 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) on movement
Time Frame: Baseline(Week 1), Week 2, 3, 8
Minimum 0, Maximum 100. Higher values represent a worse outcome
Baseline(Week 1), Week 2, 3, 8
Visual Analogue Scale (VAS) at rest
Time Frame: Baseline(Week 1), Week 2, 3, 8
Minimum 0, Maximum 100. Higher values represent a worse outcome
Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) on movement
Time Frame: Baseline(Week 1), Week 2, 3, 8
Minimum 0, Maximum 10. Higher values represent a worse outcome
Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) at rest
Time Frame: Baseline(Week 1), Week 2, 3, 8
Minimum 0, Maximum 10. Higher values represent a worse outcome
Baseline(Week 1), Week 2, 3, 8
Vernon-Mior Neck Disability Index (NDI)
Time Frame: Baseline(Week 1), Week 2, 3, 8
Functional disability questionnaire
Baseline(Week 1), Week 2, 3, 8
Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame: Baseline(Week 1), Week 2, 3, 8
Functional disability questionnaire and Pain questionnaire
Baseline(Week 1), Week 2, 3, 8
Patient Global Impression of Change (PGIC)
Time Frame: Week 3, 8
Global, patient-reported outcome, Minimum 1, Maximum 7, Higher values represent a better outcome
Week 3, 8
Range of movement (ROM) of flexion
Time Frame: Baseline(Week 1), Week 2, 3, 8
Range of movement of flexion
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 of extension
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 of Right rotation
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 of Left rotation
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 of Left lateroflexion
Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt lateroflexion
Time Frame: Baseline(Week 1), Week 2, 3, 8
Range of movement of Right lateroflexion
Baseline(Week 1), Week 2, 3, 8
EQ-5D-5L
Time Frame: Baseline(Week 1), 3, 8
Health-related quality of life questionnaire
Baseline(Week 1), 3, 8
12-item Short-Form Health Survey (SF-12)
Time Frame: Baseline(Week 1), 3, 8
Health-related quality of life questionnaire
Baseline(Week 1), 3, 8
EuroQol Visual Analogue Scale (EQ-VAS)
Time Frame: Baseline(Week 1), 3, 8
Health-related quality of life questionnaire
Baseline(Week 1), 3, 8
Adverse events
Time Frame: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
Safety outcome
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)
Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments
Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: In-Hyuk Ha, Dr., Jaseng Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-CT-2020-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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