NCT03750591

Completed

Not Applicable

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

Jaseng Medical Foundation4 sites in 1 country1,000 target enrollmentMarch 31, 2018

ConditionsSciatica Due to Intervertebral Disc Disorder Intervertebral Disc Displacement Sciatica Sciatic Radiculopathy

InterventionsHerbal medicine Chuna manual therapy Bee venom pharmacopuncture Pharmacopuncture Acupuncture Electroacupuncture Cupping Other intervention(s)

DrugsHerbal medicine

Overview

Phase: Not Applicable
Intervention: Herbal medicine
Conditions: Sciatica Due to Intervertebral Disc Disorder
Sponsor: Jaseng Medical Foundation
Enrollment: 1000
Locations: 4
Primary Endpoint: NRS change from Baseline NRS at discharge
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 31, 2018

End Date

November 8, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Jaseng Medical Foundation

Responsible Party

Principal Investigator

In-Hyuk Ha, KMD

Director

Jaseng Medical Foundation

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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)
•Patients admitted due to pain caused by traffic accidents
•Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
•Patients with severe mental illness
•Patients with difficulty or refusal to give sign written informed consent
•Patients for whom the researchers judge participation in the clinical study to be difficult
•Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI

Arms & Interventions

Integrative Korean medicine treatment group

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)

Intervention: Herbal medicine

Integrative Korean medicine treatment group

Intervention: Chuna manual therapy

Integrative Korean medicine treatment group

Intervention: Bee venom pharmacopuncture

Integrative Korean medicine treatment group

Intervention: Pharmacopuncture

Integrative Korean medicine treatment group

Intervention: Acupuncture

Integrative Korean medicine treatment group

Intervention: Electroacupuncture

Integrative Korean medicine treatment group

Intervention: Cupping

Integrative Korean medicine treatment group

Intervention: Other intervention(s)

Outcomes

Primary Outcomes

NRS change from Baseline NRS at discharge

Time Frame: Baseline (admission), discharge (up to 14 weeks after baseline)

Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.

ODI change from Baseline ODI at discharge

Time Frame: Baseline (admission), discharge (up to 14 weeks after baseline)

Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.

PGIC

Time Frame: 6 months after baseline

Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).

Secondary Outcomes

SLR from Baseline SLR at each time point(Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline))
EQ-5D change from Baseline EQ-5D at each time point(Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline)
Lumbar ROM from Baseline Lumbar ROM at each time point(Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline))
AE(up to 14 weeks after baseline)
NRS change from Baseline NRS at each timepoint(Baseline (admission), 2 weeks after baseline, 6 months after baseline)
ODI change from Baseline ODI at each timepoint(Baseline (admission), 2 weeks after baseline, 6 months after baseline)