Low Back PainNCT05493007
The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain
A study testing Sandbag motion style acupuncture treatment and Korean medical treatment in people with Low Back Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a double blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Sandbag motion style acupuncture treatment and Korean medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2021to 26 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
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
This study is a double blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment
Read the 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).
- Conditions
- Low Back Pain
- Being tested
- Sandbag motion style acupuncture treatment, Korean medical treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandbag motion style acupuncture treatmentProcedure or surgery
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.
Korean medical treatmentProcedure or surgery
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.
| Study group | Role | What they receive |
|---|---|---|
| Sandbag motion style acupuncture treatment | Experimental | The MSAT group will recieve 3 sessions of MSAT; on second, third, fourth day after hospitalization.
A trained doctor of Korean medicine with at least 3 years of clinical experience will conduct the MSAT.
The MSAT group will be also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: Sandbag motion style acupuncture treatment; Procedure: Korean medical treatment |
| Korean medical treatment | Active comparator | The control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine Receives: Procedure: Korean medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Change from baseline NRS at 4 days
Secondary outcomes (11)
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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures a patient's self-reported Low back pain related disability.
Measured: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
EuroQol 5-Dimension (EQ-5D)
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.
Measured: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
EuroQol Visual Analogue Scale (EQ-VAS)
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.
Measured: visit2(day2), day of discharge(up to 14days)
Short Form-12 Health Survey version 2 (SF-12 v2)
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.
Measured: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Patient Global Impression of Change (PGIC)
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.
Measured: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5-K)
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.
Measured: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Adverse events
Check adverse events every visit
Measured: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start17 Jul 2021
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, PhD, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493007
- Sponsor's protocol ID
- JS-CT-2021-10
- Status last verified
- Oct 2023
- First submitted
- 5 Aug 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05493007
- Acronym / sponsor ID
- JS-CT-2021-10
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sandbag motion style acupuncture treatment | Experimental | Procedure: Sandbag motion style acupuncture treatment, Procedure: Korean medical treatmentThe MSAT group will recieve 3 sessions of MSAT; on second, third, fourth day after hospitalization. A trained doctor of Korean medicine with at least 3 years of clinical experience will conduct the MSAT. The MSAT group will be also treated with other Korean medical treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. |
| Korean medical treatment | Active comparator | Procedure: Korean medical treatmentThe control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandbag motion style acupuncture treatmentMotion 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. | Procedure or surgery | Sandbag motion style acupuncture treatment |
| Korean medical treatmentacupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine. | Procedure or surgery | Korean medical treatment, Sandbag motion style acupuncture treatment |
Primary outcome
Numeric Rating Scale(NRS) of Low back pain
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'.
11 secondary outcomes
Visual Analogue Scale (VAS) of Low back pain
Time frame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
Numeric Rating Scale(NRS) of leg pain
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
Time frame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
Physical examination (Lumbar range of motion)
Time frame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)
Oswestry Disability Index (ODI)
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
EuroQol 5-Dimension (EQ-5D)
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: visit2(day2), day of discharge(up to 14days)
Short Form-12 Health Survey version 2 (SF-12 v2)
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Patient Global Impression of Change (PGIC)
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5-K)
Time frame: visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Adverse events
Time frame: visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, PhD principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sandbag motion style acupuncture treatment and Korean medical treatment in people with Low Back Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale(NRS) of Low back pain (time frame: Change from baseline NRS at 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.