Acute Neck Pain
Conditions
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.
Interventions
OTHERMotion Style Acupuncture Treatment (MSAT)
MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.
OTHERAcupuncture
General acupuncture
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale(VAS) on movement | Change from baseline VAS at 3 weeks | Minimum 0, Maximum 100. Higher values represent a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) on movement | Baseline(Week 1), Week 2, 3, 8 | Minimum 0, Maximum 100. Higher values represent a worse outcome |
| 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 |
| Northwick Park Neck Pain Questionnaire (NPQ) | Baseline(Week 1), Week 2, 3, 8 | Functional disability questionnaire and Pain questionnaire |
| 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 |
| EQ-5D-5L | 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 |
| Range of movement (ROM) of Lt rotation | Baseline(Week 1), Week 2, 3, 8 | Range of movement of Left rotation |
| 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 |
| 12-item Short-Form Health Survey (SF-12) | Baseline(Week 1), 3, 8 | Health-related quality of life questionnaire |
| EuroQol Visual Analogue Scale (EQ-VAS) | 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 |
| 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 extension | Baseline(Week 1), Week 2, 3, 8 | Range of movement of extension |
Countries
South Korea
Outcome results
None listed