Clinical trial NCT06179901: The Effect of Early MSAT Treatment on Sciatica Caused by Traffic Accidents.
Official title: The Effect of Early MSAT Treatment on Sciatica Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatica
Radiating Pain
Paresthesia
Dysesthesia
Keywords: MSAT
Sciatica
Radiating pain
Paresthesia
Dysesthesia
Acupuncture
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The stimulation of the nerve roots due to physicochemical causes can lead to symptoms along the distribution area of those nerves, such as radiating pain, numbness, a sensation of heat, dullness in sensation, muscle weakness, and more. While radiating pain and abnormal sensations typically arise from lumbar disc herniation, they can also result from peripheral nerve entrapment, like in radiculopathy. Traditional Korean medicine treatments for radiating pain involve acupuncture, pharmacoacupuncture, moxibustion, cupping and Chuna therapy.

Motion Style Acupuncture Treatment (MSAT) combines traditional acupuncture with neurophysiological theories, focusing on administering acupuncture at the affected area and subsequently involving active or passive movements. Studies have shown the efficacy of MSAT in treating various acute and chronic neuromuscular disorders like low back pain, brachial plexus injury, and temporomandibular joint disorders. Although there have been reports of the effectiveness of pelvic MSAT treatment in patients complaining of lumbar and radiating pain due to lumbar disc herniation, research on the initial effects of MSAT treatment specifically targeting traffic accident victims is still lacking. MSAT has been developed as an emergency acupuncture method that enhances blood circulation by adding movement to traditional acupuncture, offering quick pain relief and restoring range of motion.

Given the significant impact of a traffic accident, positive effects could be anticipated in alleviating radiating pain and restoring reduced range of motion through MSAT, especially when these symptoms arise following such a traumatic event.

Eligibility criteria: Inclusion Criteria:

1. a person who has no problem in language communication
2. men and women between the ages of 19 and 69
3. a patient hospitalized for treatment in a car accident
4. A person who complains of radiating pain or abnormal sensation in the lower extremities within three days after a traffic accident
5. A person with a lower extremity radiating pain or abnormal sensation of NRS (Numeric Rating Scale) 5 or higher
6. A person who voluntarily agrees to participate in clinical trials and signs a consent form

Exclusion Criteria:

1. Patient diagnosed with certain serious diseases that may cause radiation pain: malignant tumors, spinal fractures, spinal infections, inflammatory spondylitis, etc
2. Patient with progressive neurological deficits or severe neurological symptoms such as Mami syndrome
3. Patient who has undergone surgery, procedures, or is scheduled to undergo surgery on the lumbar spine or lower extremities within the last 3 weeks
4. 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
5. 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
6. Patient currently taking steroids, immunosuppressants, mental illness medications or other medications that may affect research results
7. Patient Participating in clinical trials other than observational studies without therapeutic intervention
8. Patient who has difficulty filling out consent forms to participate in research
9. Patient deemed difficult to conduct this clinical study when judged by the research director

Primary outcomes:
measure: Numeric Rating Scale of sciatica(NRS of sciatica)
timeFrame: 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:
measure: NRS of Lower back pain(NRS of LBP)
timeFrame: 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)
measure: Oswestry disability index(ODI)
timeFrame: 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)
measure: European Quality of Life-5 Dimensions(EQ-5D)
timeFrame: 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)
measure: Patient Global Impression of Change(PGIC)
timeFrame: 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)
measure: Straight Leg Raise Test(SLRT)
timeFrame: 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)
measure: Lumbar Range of motion(Lumbar ROM)
timeFrame: 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)
measure: Adverse event(AE)
timeFrame: 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)
measure: Severity of L-spine HIVD(Herniated intervertebral disc) or lumbar stenosis on MRI
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Bucheon Jaseng Hospital of Korean Medicine
name: In-Hyuk Ha, PhD
role: STUDY_CHAIR
References: