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

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)

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Medicine, Korean Traditional
• Intervention / Treatment: Procedure: T-MSAT(Motion style acupuncture treatment using traction); Procedure: Korean medicine treatment

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)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: T-MSAT(Motion style acupuncture treatment using Traction); T-MSAT group receives 3 sessions of T-MSAT; on 2nd, 3rd, 4th day after hospitalization. A trained doctor of Korean medicine with clinical experience conducted the T-MSAT. And T-MSAT group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.	Procedure: T-MSAT(Motion style acupuncture treatment using traction); 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.; Procedure: Korean medicine treatment; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
ACTIVE_COMPARATOR: Korean medicine treatment; The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.	Procedure: Korean medicine treatment; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	Change from baseline VAS at 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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.	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.	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.	Baseline, day3, day4, day of discharge(up to 14days), week12
Range of movement (ROM) of flexion	Range of movement (ROM) of flexion is measured.	Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of extension	Range of movement (ROM) of extension is measured.	Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of left lateral flexion	Range of movement (ROM) of left lateral flexion is measured.	Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of right lateral flexion	Range of movement (ROM) of right lateral flexion is measured.	Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of left rotation	Range of movement (ROM) of left rotation is measured.	Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of right rotation	Range of movement (ROM) of right rotation is measured.	Baseline, day3, day4, day of discharge(up to 14days)
Oswestry Disability Index (ODI)	Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)	Baseline, day4, day of discharge(up to 14days), week12
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)	The PCL-5(The Posttraumatic Stress Disorder Checklist for DSM-5) is a 20-item, 5-point-Likert-scale, self-report questionnaire to measure the PTSD symptoms in the DSM-536 and to diagnose PTSD. A higher score (out of 80) indicates severe PTSD.	Baseline, day4, day of discharge(up to 14days), week12
12-item Short-Form Health Survey (SF-12)	The SF-12 is a shortened version of the Short Form-36 Health Survey (SF-36), which is a widely used instrument to assess health-related quality of life. The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.	Baseline, day4, day of discharge(up to 14days), week12
Patient Global Impression of Change (PGIC)	The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.	day4, day of discharge(up to 14days), week12
Drug Consumption	Drug type and dose of prescribe for medicine, and type and frequency of other treatments	Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)
Adverse events	Safety outcome	Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Principal Investigator: In-Hyuk Ha, Dr., Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2020
• Primary Completion (ACTUAL): March 18, 2021
• Study Completion (ACTUAL): June 21, 2021

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: acupuncture therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: JS-CT-2020-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No