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

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: Completed
• Conditions: Acute Neck Pain
• Intervention / Treatment: Other: Motion Style Acupuncture Treatment (MSAT); Other: 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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale(VAS) on movement	Minimum 0, Maximum 100. Higher values represent a worse outcome	Change from baseline VAS at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) on movement	Minimum 0, Maximum 100. Higher values represent a worse outcome	Baseline(Week 1), Week 2, 3, 8
Visual Analogue Scale (VAS) at rest	Minimum 0, Maximum 100. Higher values represent a worse outcome	Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) on movement	Minimum 0, Maximum 10. Higher values represent a worse outcome	Baseline(Week 1), Week 2, 3, 8
Numeric Rating Scale (NRS) at rest	Minimum 0, Maximum 10. Higher values represent a worse outcome	Baseline(Week 1), Week 2, 3, 8
Vernon-Mior Neck Disability Index (NDI)	Functional disability questionnaire	Baseline(Week 1), Week 2, 3, 8
Northwick Park Neck Pain Questionnaire (NPQ)	Functional disability questionnaire and Pain questionnaire	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	Week 3, 8
Range of movement (ROM) of flexion	Range of movement of flexion	Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of extension	Range of movement of extension	Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt rotation	Range of movement of Right rotation	Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Lt rotation	Range of movement of Left rotation	Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Lt lateroflexion	Range of movement of Left lateroflexion	Baseline(Week 1), Week 2, 3, 8
Range of movement (ROM) of Rt lateroflexion	Range of movement of Right lateroflexion	Baseline(Week 1), Week 2, 3, 8
EQ-5D-5L	Health-related quality of life questionnaire	Baseline(Week 1), 3, 8
12-item Short-Form Health Survey (SF-12)	Health-related quality of life questionnaire	Baseline(Week 1), 3, 8
EuroQol Visual Analogue Scale (EQ-VAS)	Health-related quality of life questionnaire	Baseline(Week 1), 3, 8
Adverse events	Safety outcome	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	Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Principal Investigator: In-Hyuk Ha, Dr., Jaseng Medical Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2020
• Primary Completion (ACTUAL): November 18, 2021
• Study Completion (ACTUAL): November 18, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (ACTUAL): September 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID 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