Clinical trial NCT03750591: Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
Official title: Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sciatica Due to Intervertebral Disc Disorder
Intervertebral Disc Displacement
Sciatica
Sciatic Radiculopathy
Keywords: Integrative Korean medicine
treatment
effectiveness
safety
Lumbar intervertebral disc herniation
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine

Brief summary: Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation

Detailed description: Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction with an observational study to the aim of evaluating the effectiveness and safety of Korean medicine treatment for inpatients

Eligibility criteria: 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 Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI

Primary outcomes:
measure: NRS change from Baseline NRS at discharge
timeFrame: Baseline (admission), discharge (up to 14 weeks after baseline)
measure: ODI change from Baseline ODI at discharge
timeFrame: Baseline (admission), discharge (up to 14 weeks after baseline)
measure: PGIC
timeFrame: 6 months after baseline
Secondary outcomes:
measure: EQ-5D change from Baseline EQ-5D at each time point
timeFrame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline
measure: Lumbar ROM from Baseline Lumbar ROM at each time point
timeFrame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
measure: SLR from Baseline SLR at each time point
timeFrame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
measure: AE
timeFrame: up to 14 weeks after baseline
measure: NRS change from Baseline NRS at each timepoint
timeFrame: Baseline (admission), 2 weeks after baseline, 6 months after baseline
measure: ODI change from Baseline ODI at each timepoint
timeFrame: Baseline (admission), 2 weeks after baseline, 6 months after baseline
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Haeundae Jaseng Hospital of Korean Medicine
name: HYUN WOO CHO, PhD
role: PRINCIPAL_INVESTIGATOR
References: