Clinical trial NCT04554446: The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial
Official title: The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Medicine, Korean Traditional
Keywords: acupuncture therapy
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-09-18
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
Primary purpose: TREATMENT

Brief summary: This study is a single blind, randomized controlled trial. condition/disease: acute low-back pain treatment/intervention: Motion Style Acupuncture Treatment using Traction (T-MSAT)

Detailed description: Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.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 pain and improve musculoskeletal disfunctions. However, there has been no specific studies for the effect of this treatment.

So, investigators conduct a randomized controlled trials to verify the effectiveness and safety of T-MSAT. From September 2020 to March 2021, investigators recruit 100 inpatients who are suffered from acute low-back pain with the numeric rating scale(NRS) over 5 by traffic accident(TA). For experimental group(n=50), investigators conduct T-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 T-MSAT is conducted. For these two groups, investigators compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), , Oswestry Disability Index(ODI), the 12-Item Short Form Health Survey(SF-12), and PTSD Checklist for DSM(Diagnostic and Statistical Manual of Mental Disorders, DSM)-5(PCL-5)

Eligibility criteria: Inclusion Criteria:

* Patients aged 19-70 years on the date they sign the consent form
* Patients with NRS ≥ 5 for low-back pain
* Patients who needs hospitalization due to acute low-back pain that occurred within 7 days after traffic accident
* 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 acute low-back pain: malignancy, fracture of lumbar spine, etc.
* Patients with progressive neurological deficits or with severe neurological symptoms
* 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 difficult to walk due to leg disorder unrelated to low-back pain
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
* Patients who are pregnant, planning to become pregnant, or are breastfeeding
* Patients who have had surgery or procedures of lumbar spine within the last three weeks
* 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 low-back pain
timeFrame: Change from baseline VAS at 4 days
Secondary outcomes:
measure: Numeric Rating Scale(NRS) of low-back pain
timeFrame: baseline(day1), day2, day3, day4, day of Discharge(up to 14days), week 12
measure: Visual Analogue Scale (VAS) of low-back pain
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Visual Analogue Scale (VAS) of leg pain
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Numeric Rating Scale(NRS) of leg pain
timeFrame: Baseline, day3, day4, day of discharge(up to 14days), week12
measure: Range of movement (ROM) of flexion
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Range of movement (ROM) of extension
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Range of movement (ROM) of left lateral flexion
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Range of movement (ROM) of right lateral flexion
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Range of movement (ROM) of left rotation
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Range of movement (ROM) of right rotation
timeFrame: Baseline, day3, day4, day of discharge(up to 14days)
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, day4, day of discharge(up to 14days), week12
measure: Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
timeFrame: Baseline, day4, day of discharge(up to 14days), week12
measure: 12-item Short-Form Health Survey (SF-12)
timeFrame: Baseline, day4, day of discharge(up to 14days), week12
measure: Patient Global Impression of Change (PGIC)
timeFrame: day4, day of discharge(up to 14days), week12
measure: Drug Consumption
timeFrame: Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)
measure: Adverse events
timeFrame: Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, Dr.
role: PRINCIPAL_INVESTIGATOR
References: