Low Back PainNCT04554446

The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial

A study testing T-MSAT(Motion style acupuncture treatment using traction) and Korean medicine treatment in people with Low Back Pain and Medicine, Korean Traditional, run by Jaseng Medical Foundation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a single blind, randomized controlled trial. condition/disease: acute low-back pain treatment/intervention: Motion Style Acupuncture Treatment using Traction (T-MSAT) Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Low Back Pain, Medicine, Korean Traditional
What is being tested?: T-MSAT(Motion style acupuncture treatment using traction) and Korean medicine treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteSouth Korea
Study dates: 21 Sep 2020to 21 Jun 2021
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 with NRS ≥ 5 for low-back pain
Patients who needs hospitalization due to acute low-back pain that occurred within 7 days after traffic accident
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 acute low-back pain: malignancy, fracture of lumbar spine, etc.
Patients with progressive neurological deficits or with severe neurological symptoms
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 difficult to walk due to leg disorder unrelated to low-back pain
Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study

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Patients who are pregnant, planning to become pregnant, or are breastfeeding
Patients who have had surgery or procedures of lumbar spine within the last three weeks
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

Other trials in South Korea

About this study

This study is a single blind, randomized controlled trial. condition/disease: acute low-back pain treatment/intervention: Motion Style Acupuncture Treatment using Traction (T-MSAT)

Read the detailed description

Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.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 pain and improve musculoskeletal disfunctions. However, there has been no specific studies for the effect of this treatment.

So, investigators conduct a randomized controlled trials to verify the effectiveness and safety of T-MSAT. From September 2020 to March 2021, investigators recruit 100 inpatients who are suffered from acute low-back pain with the numeric rating scale(NRS) over 5 by traffic accident(TA). For experimental group(n=50), investigators conduct T-MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except T-MSAT is conducted. For these two groups, investigators compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), , Oswestry Disability Index(ODI), the 12-Item Short Form Health Survey(SF-12), and PTSD Checklist for DSM(Diagnostic and Statistical Manual of Mental Disorders, DSM)-5(PCL-5)

Conditions: Low Back Pain, Medicine, Korean Traditional
Being tested: T-MSAT(Motion style acupuncture treatment using traction), Korean medicine treatment
Keywords: acupuncture therapy
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.

T-MSAT(Motion style acupuncture treatment using traction)Procedure or surgery
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.
Korean medicine treatmentProcedure or surgery
acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Study groups in NCT04554446
Study group	Role	What they receive
T-MSAT(Motion style acupuncture treatment using Traction)	Experimental	T-MSAT group receives 3 sessions of T-MSAT; on 2nd, 3rd, 4th day after hospitalization. A trained doctor of Korean medicine with clinical experience conducted the T-MSAT. And T-MSAT group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: T-MSAT(Motion style acupuncture treatment using traction); Procedure: Korean medicine treatment
Korean medicine treatment	Active comparator	The control group is received Korean integrative medicine treatment everyday; acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: Korean medicine 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 acute low-back pain and discomfort was 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 participants are 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 VAS at 4 days

Secondary outcomes (16)

Numeric Rating Scale(NRS) of low-back pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participants are 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: baseline(day1), day2, day3, day4, day of Discharge(up to 14days), week 12
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: Baseline, day3, day4, day of discharge(up to 14days)
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: Baseline, day3, 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.
Measured: Baseline, day3, day4, day of discharge(up to 14days), week12
Range of movement (ROM) of flexion
Range of movement (ROM) of flexion is measured.
Measured: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of extension
Range of movement (ROM) of extension is measured.
Measured: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of left lateral flexion
Range of movement (ROM) of left lateral flexion is measured.
Measured: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of right lateral flexion
Range of movement (ROM) of right lateral flexion is measured.
Measured: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of left rotation
Range of movement (ROM) of left rotation is measured.
Measured: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of right rotation
Range of movement (ROM) of right rotation is measured.
Measured: Baseline, day3, day4, day of discharge(up to 14days)
Oswestry Disability Index (ODI)
Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)
Measured: Baseline, day4, day of discharge(up to 14days), week12
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
The PCL-5(The Posttraumatic Stress Disorder Checklist for DSM-5) is a 20-item, 5-point-Likert-scale, self-report questionnaire to measure the PTSD symptoms in the DSM-536 and to diagnose PTSD. A higher score (out of 80) indicates severe PTSD.
Measured: Baseline, day4, day of discharge(up to 14days), week12
12-item Short-Form Health Survey (SF-12)
The SF-12 is a shortened version of the Short Form-36 Health Survey (SF-36), which is a widely used instrument to assess health-related quality of life. The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Measured: Baseline, day4, day of discharge(up to 14days), week12
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: day4, day of discharge(up to 14days), week12
Drug Consumption
Drug type and dose of prescribe for medicine, and type and frequency of other treatments
Measured: Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)
Adverse events
Safety outcome
Measured: Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202021 Jun 2021

First posted18 Sep 2020
Study start21 Sep 2020
Primary completion18 Mar 2021
Study completion21 Jun 2021

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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04554446
Sponsor's protocol ID: JS-CT-2020-10
Status last verified: Jul 2021
First submitted: 7 Sep 2020
Last updated: 6 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness and Safety of T-MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents : A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04554446
Acronym / sponsor ID: JS-CT-2020-10
Conditions: Low Back Pain, Medicine, Korean Traditional
Keywords: acupuncture therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Jaseng Medical FoundationUniversity, hospital or other
Study start: 21 Sep 2020 (actual)
Primary completion: 18 Mar 2021 (actual)
Study completion: 21 Jun 2021 (actual)
First posted: 18 Sep 2020 (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 single blind, randomized controlled trial. condition/disease: acute low-back pain treatment/intervention: Motion Style Acupuncture Treatment using Traction (T-MSAT)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
T-MSAT(Motion style acupuncture treatment using Traction)	Experimental	Procedure: T-MSAT(Motion style acupuncture treatment using traction), Procedure: Korean medicine treatmentT-MSAT group receives 3 sessions of T-MSAT; on 2nd, 3rd, 4th day after hospitalization. A trained doctor of Korean medicine with clinical experience conducted the T-MSAT. And T-MSAT group is also treated with other Korean integrative medicine treatment everyday: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Korean medicine treatment	Active comparator	Procedure: Korean medicine treatmentThe control group is received Korean integrative medicine treatment everyday; 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 with NRS ≥ 5 for low-back pain
Patients who needs hospitalization due to acute low-back pain that occurred within 7 days after traffic accident
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 acute low-back pain: malignancy, fracture of lumbar spine, etc.
Patients with progressive neurological deficits or with severe neurological symptoms
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 difficult to walk due to leg disorder unrelated to low-back pain

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
T-MSAT(Motion style acupuncture treatment using traction)Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.	Procedure or surgery	T-MSAT(Motion style acupuncture treatment using Traction)
Korean medicine treatmentacupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.	Procedure or surgery	Korean medicine treatment, T-MSAT(Motion style acupuncture treatment using Traction)

Primary outcome

Numeric Rating Scale(NRS) of low-back pain
Time frame: Change from baseline VAS at 4 days
The extent of acute low-back pain and discomfort was 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 participants are 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'.

16 secondary outcomes

Numeric Rating Scale(NRS) of low-back pain
Time frame: baseline(day1), day2, day3, day4, day of Discharge(up to 14days), week 12
Visual Analogue Scale (VAS) of low-back pain
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Visual Analogue Scale (VAS) of leg pain
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Numeric Rating Scale(NRS) of leg pain
Time frame: Baseline, day3, day4, day of discharge(up to 14days), week12
Range of movement (ROM) of flexion
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of extension
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of left lateral flexion
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of right lateral flexion
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of left rotation
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Range of movement (ROM) of right rotation
Time frame: Baseline, day3, day4, day of discharge(up to 14days)
Oswestry Disability Index (ODI)
Time frame: Baseline, day4, day of discharge(up to 14days), week12
Korean version of The Posttraumatic Stress Disorder Checklist for DSM-5(PCL-5-K)
Time frame: Baseline, day4, day of discharge(up to 14days), week12
12-item Short-Form Health Survey (SF-12)
Time frame: Baseline, day4, day of discharge(up to 14days), week12
Patient Global Impression of Change (PGIC)
Time frame: day4, day of discharge(up to 14days), week12
Drug Consumption
Time frame: Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)
Adverse events
Time frame: Baseline, day3, day4, day of discharge(up to 14days), week12 (every visit)

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 6 Jul 2021.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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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, Dr. 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?

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 6 Jul 2021. 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 VAS at 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04554446.

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 6 Jul 2021.