Clinical trial NCT05493007: The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain
Official title: The Efficacy and Safety of Sandbag Self Walking-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Rating Scale(NRS) of Low back pain
timeFrame: Change from baseline NRS at 4 days
Secondary outcomes:
measure: Visual Analogue Scale (VAS) of Low back pain
timeFrame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
measure: Numeric Rating Scale(NRS) of leg pain
timeFrame: visit1(day1), visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
measure: Visual Analogue Scale (VAS) of leg pain
timeFrame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
measure: Physical examination (Lumbar range of motion)
timeFrame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
measure: Oswestry Disability Index (ODI)
timeFrame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
measure: EuroQol 5-Dimension (EQ-5D)
timeFrame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: visit2(day2), day of discharge(up to 14days)
measure: Short Form-12 Health Survey version 2 (SF-12 v2)
timeFrame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
measure: Patient Global Impression of Change (PGIC)
timeFrame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5-K)
timeFrame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
measure: Adverse events
timeFrame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, PhD
role: PRINCIPAL_INVESTIGATOR
References: