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

NCT ID: NCT04956458

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2021-12-31

Brief Summary

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This study is a single blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment

Detailed Description

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"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

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lumbar motion style acupuncture treatment

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.

Group Type EXPERIMENTAL

Lumbar motion style acupuncture treatment

Intervention Type PROCEDURE

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 treatment

The control group will be received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine

Group Type ACTIVE_COMPARATOR

Korean medical treatment

Intervention Type PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Interventions

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Lumbar motion style acupuncture treatment

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

Intervention Type PROCEDURE

Korean medical treatment

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 aged 19-70 years on the date they sign the consent form
* Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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In-Hyuk Ha, KMD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In-Hyuk Ha, PhD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

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Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 38513746 (View on PubMed)

Other Identifiers

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JS-CT-2021-04

Identifier Type: -

Identifier Source: org_study_id

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