The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain

The Efficacy and Safety of Sandbag Self Walking-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials

This study is a double blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Sandbag motion style acupuncture treatment; Procedure: Korean medical 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).

• Study Type: Interventional
• Enrollment (Actual): 104
• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sandbag motion style acupuncture treatment; 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.	Procedure: Sandbag motion style acupuncture treatment; 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.; Procedure: Korean medical treatment; acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.
Active Comparator: Korean medical treatment; The control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine	Procedure: Korean medical treatment; acupuncture treatment, chuna, pharmacoacupuncture, 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 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'.	Change from baseline NRS at 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	visit2(day2), visit3(day3), visit4(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. 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'.	visit1(day1), visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.	visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
Physical examination (Lumbar range of motion)	ROM of flexion, extension, lateral flexion, rotation will be measured.	visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
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.	visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.	visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.	visit2(day2), day of discharge(up to 14days)
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.	visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.	visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.	visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Adverse events	Check adverse events every visit	visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2021
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: JS-CT-2021-10

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