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

Jaseng Medical Foundation104 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Low Back Pain

Interventions

Sandbag motion style acupuncture treatmentPROCEDURE

Korean medical treatmentPROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

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'.

Time frame: Change from baseline NRS at 4 days

Secondary Outcomes

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.

Time frame: 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'.

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)

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.

Time frame: 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.

Time frame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)

Data from ClinicalTrials.gov

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