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Low Back PainNCT04956458

The Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain

A study testing Lumbar 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.

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 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?
Lumbar 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
96 participants
Where
1 siteSouth Korea
Study dates
19 Mar 2021to 31 Dec 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

None listed.

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
  • If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
Show all 11Show fewer
  • 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

Other trials in South Korea

About this study

Official title: The Efficacy and Safety of Lumbar MSAT on Inpatients With Acute Low Back Pain Caused by Traffic Accidents: A Randomized Controlled Trials

This study is a single 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 will conduct a randomized controlled trials to verify the efficacy and safety of Lumbar MSAT. From March 2021 to December 2021, the investigators will collect 96 inpatients who are suffered from Low back pain with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=48), the investigators will conduct MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=48), just Korean medical treatment except MSAT will be conducted. For these two groups, the investigators will compare NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Oswestry Disability Index (ODI) and EuroQol 5-Dimension (EQ-5D), Patient Global Impression of Change (PGIC)."

Conditions
Low Back Pain
Being tested
Lumbar 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.

  • Lumbar 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 groups in NCT04956458
Study groupRoleWhat they receive
Lumbar motion style acupuncture treatmentExperimentalThe 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: Lumbar motion style acupuncture treatment
Korean medical treatmentActive comparatorThe 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.

  1. 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 (8)

  1. 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(day2), day3, day4, day of discharge(up to 14days)

  2. 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: Baseline(day2), day3, day4, day of discharge(up to 14days), week12

  3. 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(day2), day3, day4, day of discharge(up to 14days)

  4. Physical examination (Lumbar range of motion)

    ROM of flexion, extension, lateral flexion, rotation will be measured.

    Measured: Baseline(day2), day3, day4, day of discharge(up to 14days)

  5. 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: Baseline(day2), day4, day of discharge(up to 14days), week12

  6. 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: Baseline(day2), day3, day4, day of discharge(up to 14days), week12

  7. 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

  8. Adverse events

    Check adverse events every visit

    Measured: Baseline(day2), day3, day4, day of discharge(up to 14days)

Timeline

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

  1. First posted9 Jul 2021
  2. Study start19 Mar 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04956458
Sponsor's protocol ID
JS-CT-2021-04
Status last verified
Aug 2022
First submitted
25 Jun 2021
Last updated
10 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kwon OB, Hwang DW, Kang DH, Yoo SJ, Lee DH, Kwon M, Jang SW, Cho HW, Kim SD, Park KS, Kim ES, Lee YJ, Kim D, Ha IH. Effectiveness of lumbar motion style acupuncture treatment on inpatients with acute low back pain: A pragmatic, randomized controlled trial. Complement Ther Med. 2024 Jun;82:103035. doi: 10.1016/j.ctim.2024.103035. Epub 2024 Mar 20.

    PubMed 38513746

Questions about this trial

What is this clinical trial studying?

A study testing Lumbar 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 0 inclusion and 11 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 Aug 2022. 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?

On the ClinicalTrials.gov record for NCT04956458, which also lists 1 linked publication.

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 Aug 2022.

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