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

Acute Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539184
• Other study ID #: JS-CT-2020-08
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: November 18, 2021

Study information

• Verified date: November 2021
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate the comparative effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) therapy for acute neck pain compared to acupuncture.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Neck Pain
• Neck Pain

Intervention

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.
• Acupuncture
General acupuncture

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province
Korea, Republic of	Haeundae Jaseng Hospital of Korean Medicine	Busan
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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