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

NCT04554446 | Completed

• 1 other identifier: JS-CT-2020-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Low Back Pain; Medicine, Korean Traditional

Keywords

acupuncture therapy

Outcome Measures

Primary Outcomes (1)

• 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'.

  Change from baseline VAS at 4 days

Secondary Outcomes (16)

• Numeric Rating Scale(NRS) of low-back pain

  baseline(day1), day2, day3, day4, day of Discharge(up to 14days), week 12

• Visual Analogue Scale (VAS) of low-back pain

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

• Visual Analogue Scale (VAS) of leg pain

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

• Numeric Rating Scale(NRS) of leg pain

  Baseline, day3, day4, day of discharge(up to 14days), week12

• Range of movement (ROM) of flexion

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

Study Arms (2)

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.

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.

Procedure: Korean medicine treatment

Interventions

T-MSAT(Motion style acupuncture treatment using traction) PROCEDURE

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.

T-MSAT(Motion style acupuncture treatment using Traction)

Korean medicine treatment PROCEDURE

acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Korean medicine treatment; T-MSAT(Motion style acupuncture treatment using Traction)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha, Dr.

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 18, 2020
• Study Start: September 21, 2020
• Primary Completion: March 18, 2021
• Study Completion: June 21, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)