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

NCT05493007 | Completed DMC

• 1 other identifier: JS-CT-2021-10
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (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'.

  Change from baseline NRS at 4 days

Secondary Outcomes (11)

• Visual Analogue Scale (VAS) of Low back pain

  visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)

• Numeric Rating Scale(NRS) of leg pain

  visit1(day1), visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)

• Visual Analogue Scale (VAS) of leg pain

  visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)

• Physical examination (Lumbar range of motion)

  visit2(day2), visit3(day3), visit4(day4), day of discharge(up to 14days)

• Oswestry Disability Index (ODI)

  visit2(day2), day of discharge(up to 14days), visit6(1 month after discharge), visit7(3 months after discharge)

Study Arms (2)

Sandbag motion style acupuncture treatment

EXPERIMENTAL

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.

Procedure: Sandbag motion style acupuncture treatment; Procedure: Korean medical treatment

Korean medical treatment

ACTIVE COMPARATOR

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

Procedure: Korean medical treatment

Interventions

Sandbag motion style acupuncture treatment 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.

Sandbag motion style acupuncture treatment

Korean medical treatment PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine.

Korean medical treatment; Sandbag motion style acupuncture treatment

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 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

You may not qualify if:

• 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.

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, PhD

  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: August 5, 2022
• First Posted: August 9, 2022
• Study Start: July 17, 2021
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)