Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896, South Korea
NCT Number: NCT05493007
This study is a double blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment
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Notify Me19 year–70 year
All sexes
Interventional
Not applicable
Seoul, Gangnam-Gu, 135-896, South Korea
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.
Time frame: Change from baseline NRS at 4 days
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: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
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: visit1(day1), visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
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)
ROM of flexion, extension, lateral flexion, rotation will be measured.
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures a patient's self-reported Low back pain related disability.
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.
Time frame: visit2(day2), day of discharge(up to 14days)
he EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
SF-12v2 Health Survey is a practical, reliable, and valid measure of physical and mental health. It assesses the same eight health domains as the SF-36v2 with one or two questions per domain: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
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.
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, making a provisional PTSD diagnosis.
Time frame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Check adverse events every visit
Jaseng Medical Foundation
Other
The Efficacy and Safety of Sandbag Self Walking-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials
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