The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury

NCT04113824 | Completed

• 1 other identifier: JS-CT-2019-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment

Conditions

Whiplash Injury of Cervical Spine; Neck Pain, Posterior

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale(NRS) of neck pain

  The extent of posterior neck pain and discomfort was assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their posterior neck pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  day 5

Secondary Outcomes (9)

• Visual Analogue Scale (VAS) of neck pain

  day 5

• Visual Analogue Scale (VAS) of arm pain

  day 5

• Numeric Rating Scale(NRS) of arm pain

  day 5

• Physical examination (Cervical range of motion)

  day 5

• Neck Disability Index (NDI)

  day 5

Study Arms (2)

trapezius motion style acupuncture treatment

EXPERIMENTAL

The MSAT group recieved 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience conducted the MSAT. The MSAT group were also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Procedure: trapezuis motion style acupuncture treatment; Procedure: other Korean medical treatment

Korean medical treatment

ACTIVE COMPARATOR

The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Procedure: other Korean medical treatment

Interventions

trapezuis motion style acupuncture treatment PROCEDURE

Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation

trapezius motion style acupuncture treatment

other Korean medical treatment PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment; trapezius motion style acupuncture treatment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident
• Patients with NRS ≥ 5 for posterior neck pain
• Patients aged 19-70 years on the date they sign the consent form
• Patients who provide consent to participate in the trial and return the informed consent form

You may not qualify if:

• Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
• Patients with progressive neurological deficits or with severe neurological symptoms
• Patients who have had surgery or procedures within the last three weeks
• The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
• Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
• Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
• If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
• Patients who are pregnant or planning to become pregnant
• Patients with a serious mental illness
• Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
• Patients who are difficult to complete the research participation agreement
• Other patients whose participation in the trial is judged by a researcher to be problematic

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (2)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha, PhD

  Jaseng Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: double blind, randomized controlled trial

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: July 3, 2019
• Primary Completion: September 7, 2019
• Study Completion: December 15, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)