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

Last updated: October 6, 2023
Sponsor: Jaseng Medical Foundation
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Treatment

Sandbag motion style acupuncture treatment

Korean medical treatment

Clinical Study ID

NCT05493007
JS-CT-2021-10
  • Ages 19-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 7days after traffic accident
  • Patients with NRS ≥ 5 for low back pain
  • Patients who provide consent to participate in the trial and return the informedconsent form

Exclusion

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 ofthe therapeutic effects or results: cardiovascular disease, kidney disease, diabeticneuropathy, dementia, epilepsy, etc.
  • Patients who are taking steroids, immunosuppressants, mental illness drugs, or otherdrugs that may affect the results of the study
  • If acupuncture is inadequate or unsafe: patients with hemorrhagic, receivinganticoagulants, 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 studieswithout 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 beproblematic.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Sandbag motion style acupuncture treatment
Phase:
Study Start date:
July 17, 2021
Estimated Completion Date:
September 26, 2022

Study 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).

Connect with a study center

  • Jaseng Hospital of Korean Medicine

    Seoul, Gangnam-Gu 135-896
    Korea, Republic of

    Site Not Available

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