Clinical trial NCT04113824: The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury
Official title: The Efficacy and Safety of Trapezius MSAT on Inpatients With Acute Whiplash Injury Caused by Traffic Accidents: A Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash Injury of Cervical Spine
Neck Pain, Posterior
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, randomized controlled trial
Primary purpose: TREATMENT

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

Detailed description: 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. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.

So, we conducted a randomized controlled trials to verify the efficacy and safety of trapezuis MSAT. From July 2019 to September 2019, we collected 100 inpatients who were suffered from posterior nick pain with the numeric rating scale(NRS) over 4 after whiplash injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Nthe amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Neck Disability Index (NDI), and EuroQol 5-Dimension (EQ-5D).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Numeric Rating Scale(NRS) of neck pain
timeFrame: day 5
Secondary outcomes:
measure: Visual Analogue Scale (VAS) of neck pain
timeFrame: day 5
measure: Visual Analogue Scale (VAS) of arm pain
timeFrame: day 5
measure: Numeric Rating Scale(NRS) of arm pain
timeFrame: day 5
measure: Physical examination (Cervical range of motion)
timeFrame: day 5
measure: Neck Disability Index (NDI)
timeFrame: day 5
measure: EuroQol 5-Dimension (EQ-5D)
timeFrame: day 5
measure: Patient Global Impression of Change (PGIC)
timeFrame: day 5
measure: Drug Consumption
timeFrame: day 5
measure: Adverse events
timeFrame: day 5
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, PhD
role: STUDY_CHAIR
References: