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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    96
  • sponsor
    Jaseng Medical Foundation
Updated on 17 July 2021
acupuncture
back pain
low back pain

Summary

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

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)."

Details
Condition Low Back Pain, Back Pain, lumbago
Treatment Korean medical treatment, Lumbar motion style acupuncture treatment
Clinical Study IdentifierNCT04956458
SponsorJaseng Medical Foundation
Last Modified on17 July 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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