The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial

Jaseng Medical Foundation100 enrolled

Overview

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)

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Low Back Pain Medicine, Korean Traditional

Interventions

T-MSAT(Motion style acupuncture treatment using traction)PROCEDURE

Korean medicine treatmentPROCEDURE

acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

Numeric Rating Scale(NRS) of low-back pain

The extent of acute low-back 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 participants are asked to report their low-back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

Time frame: Change from baseline VAS at 4 days

Secondary Outcomes

Numeric Rating Scale(NRS) of low-back pain

NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participants are asked to report their low-back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

Time frame: baseline(day1), day2, day3, day4, day of Discharge(up to 14days), week 12

Visual Analogue Scale (VAS) of low-back pain

VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end.

Time frame: Baseline, day3, day4, day of discharge(up to 14days)

Visual Analogue Scale (VAS) of leg pain

VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end.

Time frame: Baseline, day3, day4, day of discharge(up to 14days)

Numeric Rating Scale(NRS) of leg pain

NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10.

Time frame: Baseline, day3, day4, day of discharge(up to 14days), week12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.