Clinical trial NCT04539184: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Neck Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale(VAS) on movement
timeFrame: Change from baseline VAS at 3 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS) on movement
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Visual Analogue Scale (VAS) at rest
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Numeric Rating Scale (NRS) on movement
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Numeric Rating Scale (NRS) at rest
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Vernon-Mior Neck Disability Index (NDI)
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Northwick Park Neck Pain Questionnaire (NPQ)
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 3, 8
measure: Range of movement (ROM) of flexion
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Range of movement (ROM) of extension
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Range of movement (ROM) of Rt rotation
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Range of movement (ROM) of Lt rotation
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Range of movement (ROM) of Lt lateroflexion
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: Range of movement (ROM) of Rt lateroflexion
timeFrame: Baseline(Week 1), Week 2, 3, 8
measure: EQ-5D-5L
timeFrame: Baseline(Week 1), 3, 8
measure: 12-item Short-Form Health Survey (SF-12)
timeFrame: Baseline(Week 1), 3, 8
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: Baseline(Week 1), 3, 8
measure: Adverse events
timeFrame: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
measure: Drug Consumption
timeFrame: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.