The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sandbag motion style acupuncture treatment
Korean medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Patients aged 19-70 years on the date they sign the consent form
- 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 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
Sandbag 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.
EuroQol Visual Analogue Scale (EQ-VAS)
he EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Short Form-12 Health Survey version 2 (SF-12 v2)
SF-12v2 Health Survey is a practical, reliable, and valid measure of physical and mental health. It assesses the same eight health domains as the SF-36v2 with one or two questions per domain: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.
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.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5-K)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, making a provisional PTSD diagnosis.
Adverse events
Check adverse events every visit
Full Information
NCT ID
NCT05493007
First Posted
August 5, 2022
Last Updated
October 6, 2023
Sponsor
Jaseng Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05493007
Brief Title
The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain
Official Title
The Efficacy and Safety of Sandbag Self Walking-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
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
September 26, 2022 (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 double 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 conducted a randomized controlled trials to verify the efficacy and safety of Sandbag MSAT. From June 2021 to June 2023, the investigators collected 104 inpatients who were suffered from Low back pain with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=52), the investigators conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=52), just Korean medical treatment except MSAT was conducted. For these two groups, the investigators compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), the amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Oswestry Disability Index (ODI), and EuroQol 5-Dimension (EQ-5D), EuroQol Visual Analogue Scale (EQ-VAS), Short Form-12 Health Survey version 2, SF-12 v2), The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K), 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
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sandbag 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)
Sandbag 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
visit2(day2), visit3(day3), visit4(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
visit1(day1), visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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
visit2(day2), visit3(day3), visit4(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
visit2(day2), visit3(day3), visit4(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
visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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
visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Title
EuroQol Visual Analogue Scale (EQ-VAS)
Description
he EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
visit2(day2), day of discharge(up to 14days)
Title
Short Form-12 Health Survey version 2 (SF-12 v2)
Description
SF-12v2 Health Survey is a practical, reliable, and valid measure of physical and mental health. It assesses the same eight health domains as the SF-36v2 with one or two questions per domain: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.
Time Frame
visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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
visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Title
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5-K)
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, making a provisional PTSD diagnosis.
Time Frame
visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Title
Adverse events
Description
Check adverse events every visit
Time Frame
visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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 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 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
Learn more about this trial
The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain
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