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

NCT06179901 | Completed DMC

• 1 other identifier: JS-CT-2023-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sciatica; Radiating Pain; Paresthesia; Dysesthesia

Keywords

MSAT; Sciatica; Radiating pain; Paresthesia; Dysesthesia; Acupuncture

Outcome Measures

Primary Outcomes (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).

  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)

• NRS of Lower back pain(NRS of LBP)

  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)

• Oswestry disability index(ODI)

  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)

• European Quality of Life-5 Dimensions(EQ-5D)

  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)

• Patient Global Impression of Change(PGIC)

  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)

• Straight Leg Raise Test(SLRT)

  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)

Study Arms (2)

Integrative Korean Medicine Treatment group(IKMT group)

ACTIVE COMPARATOR

Procedure: Integrative Korean Medicine Treatment

MSAT group

EXPERIMENTAL

Procedure: Integrative Korean Medicine Treatment; Procedure: lower limb motion style acupuncture treatment

Interventions

Integrative Korean Medicine Treatment PROCEDURE

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

Integrative Korean Medicine Treatment group(IKMT group); MSAT group

lower limb 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.

MSAT group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

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

Sciatica; Pain; Paresthesia

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders

Study Officials

• In-Hyuk Ha, PhD

  Bucheon Jaseng Hospital of Korean Medicine

  STUDY CHAIR

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: November 12, 2023
• First Posted: December 22, 2023
• Study Start: October 30, 2023
• Primary Completion: October 6, 2024
• Study Completion: October 15, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)