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SciaticaNCT06179901

The Effect of Early MSAT Treatment on Sciatica Caused by Traffic Accidents.

A study testing Integrative Korean Medicine Treatment and lower limb motion style acupuncture treatment in people with Sciatica and Radiating 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

The investigators would like to conduct a pilot study prior to a practical randomized control study on the effectiveness of initial MSAT treatment on inpatients complaining of radiating pain and abnormal sensation in the lower extremities caused by traffic accidents. Read more about this study

Who is it for?
Ages 19 to 69 years
Conditions the study is for
Sciatica, Radiating Pain, Paresthesia
What is being tested?
Integrative Korean Medicine Treatment and lower limb motion style acupuncture treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
30 Oct 2023to 15 Oct 2024
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a person who has no problem in language communication
  • men and women between the ages of 19 and 69
  • a patient hospitalized for treatment in a car accident
  • A person who complains of radiating pain or abnormal sensation in the lower extremities within three days after a traffic accident
  • A person with a lower extremity radiating pain or abnormal sensation of NRS (Numeric Rating Scale) 5 or higher
  • A person who voluntarily agrees to participate in clinical trials and signs a consent form

Who cannot join

  • Patient diagnosed with certain serious diseases that may cause radiation pain: malignant tumors, spinal fractures, spinal infections, inflammatory spondylitis, etc
  • Patient with progressive neurological deficits or severe neurological symptoms such as Mami syndrome
  • Patient who has undergone surgery, procedures, or is scheduled to undergo surgery on the lumbar spine or lower extremities within the last 3 weeks
  • Patient with other chronic conditions that may interfere with interpretation of treatment effects or results: cardiovascular disease, kidney disease, active hepatitis, diabetic neuropathy, dementia, severe mental illness, epilepsy, etc
  • Patient who may be inadequate or unsafe with acupuncture treatment: hemorrhagic disease, people on anticoagulant therapy, people with severe cardiovascular disease, pregnancy, and infection Severe diabetic patients, seizure disorders, etc. that are concerned
  • Patient currently taking steroids, immunosuppressants, mental illness medications or other medications that may affect research results
Show all 9Show fewer
  • Patient Participating in clinical trials other than observational studies without therapeutic intervention
  • Patient who has difficulty filling out consent forms to participate in research
  • Patient deemed difficult to conduct this clinical study when judged by the research director

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 Effect of Early MSAT Treatment on Sciatica Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Clinical Trial

The investigators would like to conduct a pilot study prior to a practical randomized control study on the effectiveness of initial MSAT treatment on inpatients complaining of radiating pain and abnormal sensation in the lower extremities caused by traffic accidents.

Read the detailed description

The stimulation of the nerve roots due to physicochemical causes can lead to symptoms along the distribution area of those nerves, such as radiating pain, numbness, a sensation of heat, dullness in sensation, muscle weakness, and more. While radiating pain and abnormal sensations typically arise from lumbar disc herniation, they can also result from peripheral nerve entrapment, like in radiculopathy. Traditional Korean medicine treatments for radiating pain involve acupuncture, pharmacoacupuncture, moxibustion, cupping and Chuna therapy.

Motion Style Acupuncture Treatment (MSAT) combines traditional acupuncture with neurophysiological theories, focusing on administering acupuncture at the affected area and subsequently involving active or passive movements. Studies have shown the efficacy of MSAT in treating various acute and chronic neuromuscular disorders like low back pain, brachial plexus injury, and temporomandibular joint disorders. Although there have been reports of the effectiveness of pelvic MSAT treatment in patients complaining of lumbar and radiating pain due to lumbar disc herniation, research on the initial effects of MSAT treatment specifically targeting traffic accident victims is still lacking. MSAT has been developed as an emergency acupuncture method that enhances blood circulation by adding movement to traditional acupuncture, offering quick pain relief and restoring range of motion.

Given the significant impact of a traffic accident, positive effects could be anticipated in alleviating radiating pain and restoring reduced range of motion through MSAT, especially when these symptoms arise following such a traumatic event.

Being tested
Integrative Korean Medicine Treatment, lower limb motion style acupuncture treatment
Keywords
MSAT, Sciatica, Radiating pain, Paresthesia, Dysesthesia, Acupuncture
Medical subject headings
Sciatica, Pain, Paresthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrative Korean Medicine TreatmentProcedure or surgery

    acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine, cupping, moxibustion.

  • lower limb 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.

Study groups in NCT06179901
Study groupRoleWhat they receive
Integrative Korean Medicine Treatment group(IKMT group)Active comparatorNot described
Receives: Procedure: Integrative Korean Medicine Treatment
MSAT groupExperimentalNot described
Receives: Procedure: Integrative Korean Medicine Treatment; Procedure: lower limb motion style acupuncture treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Rating Scale of sciatica(NRS of sciatica)

    The degree of radiation pain or abnormal sensation in the patient is evaluated through a numerical pain scale. The numerical pain scale is an index expressed by objectifying the degree of subjective pain into numbers for patients over 12 years of age who can communicate and understand the concept of numbers. The patient's pain level is quantified by zero pain and ten pain that cannot be tolerated as death, and is mild (1-4 points), moderate (5-6 points), and severe (7-10 points).

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

Secondary outcomes (8)
  1. NRS of Lower back pain(NRS of LBP)

    In addition to radiation pain and abnormal sensation, the degree of additional low back pain is evaluated together on a numerical pain scale. Write the degree of pain of the patient by stating that the state without pain at all is 0, and the pain that cannot be tolerated as if dying is 10.

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  2. Oswestry disability index(ODI)

    It is a questionnaire that measures the discomfort patients feel in their daily lives due to back pain, radiating pain in the lower extremities, and abnormal sensations. It is a functional evaluation tool that measures the availability of 10 daily activity.

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  3. European Quality of Life-5 Dimensions(EQ-5D)

    EQ-5D is one of the most widely used tools in the health care sector to measure health-related quality of life (HRQOL). It is a questionnaire that evaluates the current HRQOL by dividing it into five categories: mobility (M), self-care (SC), user activity (UA), pain/disability (PD), and anxiety/depression (AD). Each item is evaluated in Phase 1 (no problem at all), Phase 2 (slight problem), Phase 3 (moderate problem), Phase 4 (severe problem), and Phase 5 (severe problem).

    The EQ-5D Index is an index that calculates health status as a quantitative single value by assigning quality weights to each of the five items of EQ-5D. In this study, quality weights for Koreans at the Korea Centers for Disease Control and Prevention are used and calculated as in the formula below.

    EQ-5D Index

    = = 1 - (0.05 + 0.096 × M2 + 0.418 × M3 + 0.046 × SC2 + 0.136 × SC3 + 0.051 × UA2 + 0.208 × UA3 + 0.037 × PD2 + 0.151 × PD3 + 0.043 × AD2 + 0.158 × AD3 + 0.050 × N3)

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  4. Patient Global Impression of Change(PGIC)

    PGIC is an index that subjectively evaluates the degree of improvement after treatment by patients. The subjective criteria for improvement and deterioration are ambiguous, so it is usually used as a tool to evaluate treatment satisfaction. The criteria can be checked by analyzing changes in pain and dysfunction indicators for patients who are satisfied with treatment.

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  5. Straight Leg Raise Test(SLRT)

    It is a physical test performed on patients complaining of urticaria and radial pain and is performed in an supine position. The examiner holds the patient's heel with one hand, holds the patient's knee with the other hand, and raises his leg to bend the hip joint while fixing it so that the patient's knee does not bend. Check the angle at which the patient feels uncomfortable with back pain or radiating pain.

    If the knee muscle is a problem when the lower extremity is upright, it is simply related to the back of the thigh, and if the lower extremity radiating pain appears along with nerve driving, it is considered positive. If there is a space-occupying disease such as intervertebral disc hernia, it may indicate back pain or radial pain on the affected side during the tendon examination. Since it is a method of reproducing the patient's pain, the tendon leg is performed first and then the affected leg is examined.

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  6. Lumbar Range of motion(Lumbar ROM)

    Measure the active range of lumbar flexion, extension, lateral flexion, and rotation. Evaluate whether there is a limitation in the range of motion due to the patient's back pain and radiating pain.

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  7. Adverse event(AE)

    It refers to undesirable and unintended objective symptoms, subjective symptoms, or diseases that appear after the procedure during the clinical trial process. It is not necessary to have a causal relationship with the procedure. During the study period, it is collected through patient symptom reports and researcher observations, and the causal relationship between the types of adverse reactions and treatment interventions is written on the EMR. Follow-up observation is conducted when an adverse reaction occurs, and if a serious level of adverse reaction is found, report it quickly.

    Measured: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)

  8. Severity of L-spine HIVD(Herniated intervertebral disc) or lumbar stenosis on MRI

    Data is collected retrospectively through EMR records for research patients who took L-SPINE MRI. The degree of escape and stenosis of the intervertebral disc on MRI is divided into mild, subtle, moderate, and severe. The stage of intervertebral disc escape is divided into bulding, protusion, extrusion, and sequencing, and the direction of escape is classified into central, subarticular, formal, lateral, and interior. Stenosis will be classified as central, lateral repair, and formal. L-spine MRI is evaluated through retrospective chart review during the study period regardless of the patient's admission and discharge.

    Measured: through study completion, an average of 1 month

Timeline

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

  1. First posted22 Dec 2023
  2. Study start30 Oct 2023
  3. Primary completion6 Oct 2024
  4. Study completion15 Oct 2024

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179901
Sponsor's protocol ID
JS-CT-2023-07
Status last verified
Mar 2025
First submitted
12 Nov 2023
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim J, Kim SR, Seo M, Lee D, Yoo SJ, Sun M, Lee Y, Heo I, Shin WC, Cho JH, Seo BK, Lee YJ, Kim D, Ha IH. Effects of Hip Joint Motion-Style Acupuncture Treatment in Patients with Acute Radiating Leg Symptoms After Traffic Accidents: A Pilot Pragmatic Randomized Controlled Trial. J Pain Res. 2026 Apr 21;19:597299. doi: 10.2147/JPR.S597299. eCollection 2026.

    PubMed 42039236

Questions about this trial

What is this clinical trial studying?

A study testing Integrative Korean Medicine Treatment and lower limb motion style acupuncture treatment in people with Sciatica and Radiating 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 6 inclusion and 9 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 19 Mar 2025. 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 of sciatica(NRS of sciatica) (time frame: visit 1 (Admission 1 day), visit 2 (Hospital day 2), visit 3(Hospital day 3), visit 4 (Hospital day 4), visit 5 (Hospital day 5), visit 6 (Discharge 1 day), visit 7 (13 day after admission)). 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 NCT06179901, 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 19 Mar 2025.

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