The Efficacy and Safety of Sandbag Self Walking-MSAT on Acute Low Back Pain

NCT ID: NCT05493007

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-17
• Study Completion Date: 2022-09-26

Brief Summary

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).

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sandbag 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

Sandbag 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

Intervention Type: PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.

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

Sandbag 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

Inclusion Criteria

• 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

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

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha, PhD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Countries

South Korea

Other Identifiers

JS-CT-2021-10

Identifier Type: -

Identifier Source: org_study_id