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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Neck Pain

Intervention / Treatment
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* Other: Motion Style Acupuncture Treatment (MSAT)
* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motion Style Acupuncture treatment<br>Motion Style Acupuncture treatment (2-3 times/week, 2 weeks) | Other: Motion Style Acupuncture Treatment (MSAT)<br>* MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.<br>|
| Active Comparator: Acupuncture treatment<br>Acupuncture treatment (2-3 times/week, 2 weeks) | Other: Acupuncture<br>* General acupuncture<br>|

What is the study measuring?
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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) |