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

• Sponsor: Jaseng Medical Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT04539184
• Collaborator: (none)
• Enrollment: 128
• Locations: 4
• Arms: 2
• Actual Duration (Months): 14.3
• Patients Per Site: 32
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Neck Pain	Other: Motion Style Acupuncture Treatment (MSAT); Other: Acupuncture	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness and Cost-effectiveness of Motion Style Acupuncture Treatment (MSAT) for Acute Neck Pain: A Multi-center Randomized Controlled Trial
• Actual Study Start Date: Sep 10, 2020
• Actual Primary Completion Date: Nov 18, 2021
• Actual Study Completion Date: Nov 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motion Style Acupuncture treatment Motion Style Acupuncture treatment (2-3 times/week, 2 weeks)	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.
Active Comparator: Acupuncture treatment Acupuncture treatment (2-3 times/week, 2 weeks)	Other: Acupuncture; General acupuncture

Outcome Measures

Primary Outcome Measures

1. 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

1. Visual Analogue Scale (VAS) on movement [Baseline(Week 1), Week 2, 3, 8]

   Minimum 0, Maximum 100. Higher values represent a worse outcome

2. Visual Analogue Scale (VAS) at rest [Baseline(Week 1), Week 2, 3, 8]

   Minimum 0, Maximum 100. Higher values represent a worse outcome

3. Numeric Rating Scale (NRS) on movement [Baseline(Week 1), Week 2, 3, 8]

   Minimum 0, Maximum 10. Higher values represent a worse outcome

4. Numeric Rating Scale (NRS) at rest [Baseline(Week 1), Week 2, 3, 8]

   Minimum 0, Maximum 10. Higher values represent a worse outcome

5. Vernon-Mior Neck Disability Index (NDI) [Baseline(Week 1), Week 2, 3, 8]

   Functional disability questionnaire

6. Northwick Park Neck Pain Questionnaire (NPQ) [Baseline(Week 1), Week 2, 3, 8]

   Functional disability questionnaire and Pain questionnaire

7. Patient Global Impression of Change (PGIC) [Week 3, 8]

   Global, patient-reported outcome, Minimum 1, Maximum 7, Higher values represent a better outcome

8. Range of movement (ROM) of flexion [Baseline(Week 1), Week 2, 3, 8]

   Range of movement of flexion

9. Range of movement (ROM) of extension [Baseline(Week 1), Week 2, 3, 8]

   Range of movement of extension

10. Range of movement (ROM) of Rt rotation [Baseline(Week 1), Week 2, 3, 8]

    Range of movement of Right rotation

11. Range of movement (ROM) of Lt rotation [Baseline(Week 1), Week 2, 3, 8]

    Range of movement of Left rotation

12. Range of movement (ROM) of Lt lateroflexion [Baseline(Week 1), Week 2, 3, 8]

    Range of movement of Left lateroflexion

13. Range of movement (ROM) of Rt lateroflexion [Baseline(Week 1), Week 2, 3, 8]

    Range of movement of Right lateroflexion

14. EQ-5D-5L [Baseline(Week 1), 3, 8]

    Health-related quality of life questionnaire

15. 12-item Short-Form Health Survey (SF-12) [Baseline(Week 1), 3, 8]

    Health-related quality of life questionnaire

16. EuroQol Visual Analogue Scale (EQ-VAS) [Baseline(Week 1), 3, 8]

    Health-related quality of life questionnaire

17. Adverse events [Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)]

    Safety outcome

18. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu	Korea, Republic of	135-896
2	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province	Korea, Republic of	14598
3	Haeundae Jaseng Hospital of Korean Medicine	Busan		Korea, Republic of
4	Daejeon Jaseng Hospital of Korean Medicine	Daejeon		Korea, Republic of	35262

Sponsors and Collaborators

• Jaseng Medical Foundation

Investigators

• Principal Investigator: In-Hyuk Ha, Dr., Jaseng Medical Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
• ClinicalTrials.gov Identifier: NCT04539184
• Other Study ID Numbers: JS-CT-2020-08
• First Posted: Sep 4, 2020
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neck Pain

Study Results

No Results Posted as of Nov 19, 2021