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

Primary Purpose

Acute Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Motion Style Acupuncture Treatment (MSAT)
Acupuncture
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Neck Pain

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaseng Hospital of Korean Medicine
  • Bucheon Jaseng Hospital of Korean Medicine
  • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motion Style Acupuncture treatment

Acupuncture treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Analogue Scale(VAS) on movement
Minimum 0, Maximum 100. Higher values represent a worse outcome

Secondary Outcome Measures

Visual Analogue Scale (VAS) on movement
Minimum 0, Maximum 100. Higher values represent a worse outcome
Visual Analogue Scale (VAS) at rest
Minimum 0, Maximum 100. Higher values represent a worse outcome
Numeric Rating Scale (NRS) on movement
Minimum 0, Maximum 10. Higher values represent a worse outcome
Numeric Rating Scale (NRS) at rest
Minimum 0, Maximum 10. Higher values represent a worse outcome
Vernon-Mior Neck Disability Index (NDI)
Functional disability questionnaire
Northwick Park Neck Pain Questionnaire (NPQ)
Functional disability questionnaire and Pain questionnaire
Patient Global Impression of Change (PGIC)
Global, patient-reported outcome, Minimum 1, Maximum 7, Higher values represent a better outcome
Range of movement (ROM) of flexion
Range of movement of flexion
Range of movement (ROM) of extension
Range of movement of extension
Range of movement (ROM) of Rt rotation
Range of movement of Right rotation
Range of movement (ROM) of Lt rotation
Range of movement of Left rotation
Range of movement (ROM) of Lt lateroflexion
Range of movement of Left lateroflexion
Range of movement (ROM) of Rt lateroflexion
Range of movement of Right lateroflexion
EQ-5D-5L
Health-related quality of life questionnaire
12-item Short-Form Health Survey (SF-12)
Health-related quality of life questionnaire
EuroQol Visual Analogue Scale (EQ-VAS)
Health-related quality of life questionnaire
Adverse events
Safety outcome
Drug Consumption
Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments

Full Information

First Posted
August 26, 2020
Last Updated
November 18, 2021
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04539184
Brief Title
The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial
Official Title
The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motion Style Acupuncture treatment
Arm Type
Experimental
Arm Description
Motion Style Acupuncture treatment (2-3 times/week, 2 weeks)
Arm Title
Acupuncture treatment
Arm Type
Active Comparator
Arm Description
Acupuncture treatment (2-3 times/week, 2 weeks)
Intervention Type
Other
Intervention Name(s)
Motion Style Acupuncture Treatment (MSAT)
Intervention Description
MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
General acupuncture
Primary Outcome Measure Information:
Title
Visual Analogue Scale(VAS) on movement
Description
Minimum 0, Maximum 100. Higher values represent a worse outcome
Time Frame
Change from baseline VAS at 3 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) on movement
Description
Minimum 0, Maximum 100. Higher values represent a worse outcome
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Visual Analogue Scale (VAS) at rest
Description
Minimum 0, Maximum 100. Higher values represent a worse outcome
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Numeric Rating Scale (NRS) on movement
Description
Minimum 0, Maximum 10. Higher values represent a worse outcome
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Numeric Rating Scale (NRS) at rest
Description
Minimum 0, Maximum 10. Higher values represent a worse outcome
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Vernon-Mior Neck Disability Index (NDI)
Description
Functional disability questionnaire
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Northwick Park Neck Pain Questionnaire (NPQ)
Description
Functional disability questionnaire and Pain questionnaire
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Patient Global Impression of Change (PGIC)
Description
Global, patient-reported outcome, Minimum 1, Maximum 7, Higher values represent a better outcome
Time Frame
Week 3, 8
Title
Range of movement (ROM) of flexion
Description
Range of movement of flexion
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Range of movement (ROM) of extension
Description
Range of movement of extension
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Range of movement (ROM) of Rt rotation
Description
Range of movement of Right rotation
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Range of movement (ROM) of Lt rotation
Description
Range of movement of Left rotation
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Range of movement (ROM) of Lt lateroflexion
Description
Range of movement of Left lateroflexion
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
Range of movement (ROM) of Rt lateroflexion
Description
Range of movement of Right lateroflexion
Time Frame
Baseline(Week 1), Week 2, 3, 8
Title
EQ-5D-5L
Description
Health-related quality of life questionnaire
Time Frame
Baseline(Week 1), 3, 8
Title
12-item Short-Form Health Survey (SF-12)
Description
Health-related quality of life questionnaire
Time Frame
Baseline(Week 1), 3, 8
Title
EuroQol Visual Analogue Scale (EQ-VAS)
Description
Health-related quality of life questionnaire
Time Frame
Baseline(Week 1), 3, 8
Title
Adverse events
Description
Safety outcome
Time Frame
Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
Title
Drug Consumption
Description
Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments
Time Frame
Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, Dr.
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi Province
ZIP/Postal Code
14598
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
ZIP/Postal Code
35262
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33126334
Citation
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.
Results Reference
derived

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

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