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The Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lumbar motion style acupuncture treatment
Korean medical 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

Eligibility Criteria

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

Criteria: Inclusion Criteria:

  • Patients who needs hospitalization due to acute low back pain that occurred within 7 days after traffic accident
  • Patients with NRS ≥ 5 for low back 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

Sites / Locations

  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbar motion style acupuncture treatment

Korean medical treatment

Arm Description

The MSAT group will recieve 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience will conduct the MSAT. The MSAT group will be also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

The control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine

Outcomes

Primary Outcome Measures

Numeric Rating Scale(NRS) of Low back pain
The extent of Low back pain and discomfort will be 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 participant is 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

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.
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. The participant is asked to report their leg 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 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.
Physical examination (Lumbar range of motion)
ROM of flexion, extension, lateral flexion, rotation will be measured.
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures a patient's self-reported Low back pain related disability.
EuroQol 5-Dimension (EQ-5D)
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
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.
Adverse events
Check adverse events every visit

Full Information

First Posted
June 25, 2021
Last Updated
August 8, 2022
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04956458
Brief Title
The Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain
Official Title
The Efficacy and Safety of Lumbar MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a single blind, randomized controlled trail. condition/disease: acute low back 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, the investigators will conduct a randomized controlled trials to verify the efficacy and safety of Lumbar MSAT. From March 2021 to December 2021, the investigators will collect 96 inpatients who are suffered from Low back pain with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=48), the investigators will conduct MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=48), just Korean medical treatment except MSAT will be conducted. For these two groups, the investigators will compare NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Oswestry Disability Index (ODI) and EuroQol 5-Dimension (EQ-5D), Patient Global Impression of Change (PGIC)."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lumbar motion style acupuncture treatment
Arm Type
Experimental
Arm Description
The MSAT group will recieve 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience will conduct the MSAT. The MSAT group will be also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Arm Title
Korean medical treatment
Arm Type
Active Comparator
Arm Description
The control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine
Intervention Type
Procedure
Intervention Name(s)
Lumbar motion style acupuncture treatment
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Korean medical treatment
Intervention Description
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of Low back pain
Description
The extent of Low back pain and discomfort will be 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 participant is 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 NRS at 4 days
Secondary Outcome Measure Information:
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(day2), 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. The participant is asked to report their leg 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(day2), day3, day4, day of discharge(up to 14days), week12
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(day2), day3, day4, day of discharge(up to 14days)
Title
Physical examination (Lumbar range of motion)
Description
ROM of flexion, extension, lateral flexion, rotation will be measured.
Time Frame
Baseline(day2), day3, day4, day of discharge(up to 14days)
Title
Oswestry Disability Index (ODI)
Description
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures a patient's self-reported Low back pain related disability.
Time Frame
Baseline(day2), day4, day of discharge(up to 14days), week12
Title
EuroQol 5-Dimension (EQ-5D)
Description
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Time Frame
Baseline(day2), day3, 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
Adverse events
Description
Check adverse events every visit
Time Frame
Baseline(day2), day3, day4, day of discharge(up to 14days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Inclusion Criteria: Patients who needs hospitalization due to acute low back pain that occurred within 7 days after traffic accident Patients with NRS ≥ 5 for low back 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, PhD
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 Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain

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