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

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

This study is a single 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: Korean medical treatment; Procedure: Lumbar 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)."

• Study Type: Interventional
• Enrollment (Actual): 96
• 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

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

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: Lumbar 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: Lumbar 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
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.	Baseline(day2), 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. 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'.	Baseline(day2), day3, day4, day of discharge(up to 14days), week12
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(day2), day3, day4, day of discharge(up to 14days)
Physical examination (Lumbar range of motion)	ROM of flexion, extension, lateral flexion, rotation will be measured.	Baseline(day2), day3, 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.	Baseline(day2), day4, day of discharge(up to 14days), week12
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.	Baseline(day2), day3, 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
Adverse events	Check adverse events every visit	Baseline(day2), day3, day4, day of discharge(up to 14days)

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2021
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (ACTUAL): July 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

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-2021-04

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