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Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniatio

Not Applicable
Completed
Conditions
Diseases of the musculoskeletal system and connective tissue
Registration Number
KCT0003709
Lead Sponsor
Jaseng Medical Foundation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
1000
Inclusion Criteria

1)Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
2)Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
3)Patients whose pain intensity of back pain or radiating leg pain is NRS=5
4)Patients aged 19 to 70
5)Patients who have agreed to participate in the clinical study and given written informed consent
6)Patients admitted to a Korean medicine hospital for treatment

Exclusion Criteria

1)Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
2)Patients admitted due to pain caused by traffic accidents
3)Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
4)Patients with severe mental illness
5)Patients with difficulty or refusal to give sign written informed consent
6)Patients for whom the researchers judge participation in the clinical study to be difficult
7)Diagnosis of lumbar spondylolisthesis of Meyerding ? or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Oswestry Disability Index(ODI);Patient global impression of change (PGIC);Numeric rating scale (NRS) of low back pain, and radiating leg pain
Secondary Outcome Measures
NameTimeMethod
EuroQol-5 Dimension(EQ-5D);Lumbar Range of Motion (FLEX/EXT/LAT/ROTATION);Straight Leg Raise test(SLR test);Adverse events
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