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

Not Applicable

Completed

• Conditions: Acute Neck Pain
• Interventions: Other: Motion Style Acupuncture Treatment (MSAT); Other: Acupuncture

• Registration Number: NCT04539184
• Lead Sponsor: Jaseng Medical Foundation

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-04
• Study Start: 2020-09-10
• Status Verified: 2021-11
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-18
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motion Style Acupuncture treatment	Motion Style Acupuncture Treatment (MSAT)	Motion Style Acupuncture treatment (2-3 times/week, 2 weeks)
Acupuncture treatment	Acupuncture	Acupuncture treatment (2-3 times/week, 2 weeks)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)	Week 3, 8	Global, patient-reported outcome, Minimum 1, Maximum 7, Higher values represent a better outcome
Range of movement (ROM) of flexion	Baseline(Week 1), Week 2, 3, 8	Range of movement of flexion
Drug Consumption	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
Range of movement (ROM) of Lt lateroflexion	Baseline(Week 1), Week 2, 3, 8	Range of movement of Left lateroflexion
Range of movement (ROM) of Rt lateroflexion	Baseline(Week 1), Week 2, 3, 8	Range of movement of Right lateroflexion
EQ-5D-5L	Baseline(Week 1), 3, 8	Health-related quality of life questionnaire
Visual Analogue Scale (VAS) on movement	Baseline(Week 1), Week 2, 3, 8	Minimum 0, Maximum 100. Higher values represent a worse outcome
Northwick Park Neck Pain Questionnaire (NPQ)	Baseline(Week 1), Week 2, 3, 8	Functional disability questionnaire and Pain questionnaire
Range of movement (ROM) of Lt rotation	Baseline(Week 1), Week 2, 3, 8	Range of movement of Left rotation
12-item Short-Form Health Survey (SF-12)	Baseline(Week 1), 3, 8	Health-related quality of life questionnaire
Adverse events	Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)	Safety outcome
Range of movement (ROM) of extension	Baseline(Week 1), Week 2, 3, 8	Range of movement of extension
Visual Analogue Scale (VAS) at rest	Baseline(Week 1), Week 2, 3, 8	Minimum 0, Maximum 100. Higher values represent a worse outcome
Numeric Rating Scale (NRS) on movement	Baseline(Week 1), Week 2, 3, 8	Minimum 0, Maximum 10. Higher values represent a worse outcome
Numeric Rating Scale (NRS) at rest	Baseline(Week 1), Week 2, 3, 8	Minimum 0, Maximum 10. Higher values represent a worse outcome
Vernon-Mior Neck Disability Index (NDI)	Baseline(Week 1), Week 2, 3, 8	Functional disability questionnaire
EuroQol Visual Analogue Scale (EQ-VAS)	Baseline(Week 1), 3, 8	Health-related quality of life questionnaire
Range of movement (ROM) of Rt rotation	Baseline(Week 1), Week 2, 3, 8	Range of movement of Right rotation

Trial Locations

Locations (4)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of

Haeundae Jaseng Hospital of Korean Medicine; 🇰🇷 Busan, Korea, Republic of

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of