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

Primary Purpose

Low Back Pain, Medicine, Korean Traditional

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
T-MSAT(Motion style acupuncture treatment using traction)
Korean medicine treatment
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring acupuncture therapy

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T-MSAT(Motion style acupuncture treatment using Traction)

Korean medicine treatment

Arm Description

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.

The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'.
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.
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.
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.
Range of movement (ROM) of flexion
Range of movement (ROM) of flexion is measured.
Range of movement (ROM) of extension
Range of movement (ROM) of extension is measured.
Range of movement (ROM) of left lateral flexion
Range of movement (ROM) of left lateral flexion is measured.
Range of movement (ROM) of right lateral flexion
Range of movement (ROM) of right lateral flexion is measured.
Range of movement (ROM) of left rotation
Range of movement (ROM) of left rotation is measured.
Range of movement (ROM) of right rotation
Range of movement (ROM) of right rotation is measured.
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)
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.
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.
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.
Drug Consumption
Drug type and dose of prescribe for medicine, and type and frequency of other treatments
Adverse events
Safety outcome

Full Information

First Posted
September 7, 2020
Last Updated
July 1, 2021
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04554446
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Medicine, Korean Traditional
Keywords
acupuncture therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-MSAT(Motion style acupuncture treatment using Traction)
Arm Type
Experimental
Arm Description
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.
Arm Title
Korean medicine treatment
Arm Type
Active Comparator
Arm Description
The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Intervention Type
Procedure
Intervention Name(s)
T-MSAT(Motion style acupuncture treatment using traction)
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Korean medicine treatment
Intervention Description
acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of low-back pain
Description
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 Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of low-back pain
Description
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
Title
Visual Analogue Scale (VAS) of low-back pain
Description
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)
Title
Visual Analogue Scale (VAS) of leg pain
Description
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)
Title
Numeric Rating Scale(NRS) of leg pain
Description
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
Title
Range of movement (ROM) of flexion
Description
Range of movement (ROM) of flexion is measured.
Time Frame
Baseline, day3, day4, day of discharge(up to 14days)
Title
Range of movement (ROM) of extension
Description
Range of movement (ROM) of extension is measured.
Time Frame
Baseline, day3, day4, day of discharge(up to 14days)
Title
Range of movement (ROM) of left lateral flexion
Description
Range of movement (ROM) of left lateral flexion is measured.
Time Frame
Baseline, day3, day4, day of discharge(up to 14days)
Title
Range of movement (ROM) of right lateral flexion
Description
Range of movement (ROM) of right lateral flexion is measured.
Time Frame
Baseline, day3, day4, day of discharge(up to 14days)
Title
Range of movement (ROM) of left rotation
Description
Range of movement (ROM) of left rotation is measured.
Time Frame
Baseline, day3, day4, day of discharge(up to 14days)
Title
Range of movement (ROM) of right rotation
Description
Range of movement (ROM) of right rotation is measured.
Time Frame
Baseline, day3, day4, day of discharge(up to 14days)
Title
Oswestry Disability Index (ODI)
Description
Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)
Time Frame
Baseline, day4, day of discharge(up to 14days), week12
Title
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
Description
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.
Time Frame
Baseline, day4, day of discharge(up to 14days), week12
Title
12-item Short-Form Health Survey (SF-12)
Description
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.
Time Frame
Baseline, day4, day of discharge(up to 14days), week12
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
day4, day of discharge(up to 14days), week12
Title
Drug Consumption
Description
Drug type and dose of prescribe for medicine, and type and frequency of other treatments
Time Frame
Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)
Title
Adverse events
Description
Safety outcome
Time Frame
Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, Dr.
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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