Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation

Jaseng Medical Foundation

Status: Completed

Conditions: Sciatic Radiculopathy; Sciatica; Intervertebral Disc Displacement; Sciatica Due to Intervertebral Disc Disorder

Treatments: Procedure: Bee venom pharmacopuncture; Procedure: Chuna manual therapy; Other: Other intervention(s); Procedure: Cupping; Procedure: Acupuncture; Procedure: Pharmacopuncture; Procedure: Electroacupuncture; Drug: Herbal medicine

Study type: Observational

Funder types: Other

Identifiers

NCT03750591

JS-CT-2017-05-1

Details and patient eligibility

About

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

Full 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

Enrollment: 1,000 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Integrative Korean medicine treatment group

Description:

Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals Interventions: Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)

Treatment:

Drug: Herbal medicine

Other: Other intervention(s)

Procedure: Acupuncture

Procedure: Electroacupuncture

Procedure: Pharmacopuncture

Procedure: Cupping

Procedure: Bee venom pharmacopuncture

Procedure: Chuna manual therapy