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Completed

NCT Number: NCT04539184

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

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

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Key information

Conditions

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Hospital of Korean Medicine, Seoul, Gangnam-Gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motion Style Acupuncture Treatment (MSAT)

Other

MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.

Acupuncture

Other

General acupuncture

Primary outcomes

  1. Visual Analogue Scale(VAS) on movement

    Time frame: Change from baseline VAS at 3 weeks

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

Secondary outcomes

  1. Visual Analogue Scale (VAS) on movement

    Time frame: Baseline(Week 1), Week 2, 3, 8

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

  2. Visual Analogue Scale (VAS) at rest

    Time frame: Baseline(Week 1), Week 2, 3, 8

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

  3. Numeric Rating Scale (NRS) on movement

    Time frame: Baseline(Week 1), Week 2, 3, 8

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

  4. Numeric Rating Scale (NRS) at rest

    Time frame: Baseline(Week 1), Week 2, 3, 8

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

  5. Vernon-Mior Neck Disability Index (NDI)

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Functional disability questionnaire

  6. Northwick Park Neck Pain Questionnaire (NPQ)

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Functional disability questionnaire and Pain questionnaire

  7. Patient Global Impression of Change (PGIC)

    Time frame: Week 3, 8

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

  8. Range of movement (ROM) of flexion

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Range of movement of flexion

  9. Range of movement (ROM) of extension

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Range of movement of extension

  10. Range of movement (ROM) of Rt rotation

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Range of movement of Right rotation

  11. Range of movement (ROM) of Lt rotation

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Range of movement of Left rotation

  12. Range of movement (ROM) of Lt lateroflexion

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Range of movement of Left lateroflexion

  13. Range of movement (ROM) of Rt lateroflexion

    Time frame: Baseline(Week 1), Week 2, 3, 8

    Range of movement of Right lateroflexion

  14. EQ-5D-5L

    Time frame: Baseline(Week 1), 3, 8

    Health-related quality of life questionnaire

  15. 12-item Short-Form Health Survey (SF-12)

    Time frame: Baseline(Week 1), 3, 8

    Health-related quality of life questionnaire

  16. EuroQol Visual Analogue Scale (EQ-VAS)

    Time frame: Baseline(Week 1), 3, 8

    Health-related quality of life questionnaire

  17. Adverse events

    Time frame: Time Frame: Baseline (Week 1), Week 2, 3, 8 (every visit)

    Safety outcome

  18. Drug Consumption

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2020
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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