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

Completed

• Conditions: Sciatica Due to Intervertebral Disc Disorder; Intervertebral Disc Displacement; Sciatica; Sciatic Radiculopathy
• Interventions: Drug: Herbal medicine; Procedure: Chuna manual therapy; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s)

• Registration Number: NCT03750591
• Lead Sponsor: Jaseng Medical Foundation

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

Study Timeline

• Study Start: 2018-03-31
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Primary Completion: 2019-05-10
• Study Completion: 2019-11-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integrative Korean medicine treatment group	Bee venom pharmacopuncture	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)
Integrative Korean medicine treatment group	Pharmacopuncture	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)
Integrative Korean medicine treatment group	Acupuncture	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)
Integrative Korean medicine treatment group	Herbal medicine	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)
Integrative Korean medicine treatment group	Chuna manual therapy	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)
Integrative Korean medicine treatment group	Cupping	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)
Integrative Korean medicine treatment group	Other intervention(s)	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)
Integrative Korean medicine treatment group	Electroacupuncture	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)

Primary Outcome Measures

Name	Time	Method
NRS change from Baseline NRS at discharge	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	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	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 Outcome Measures

Name	Time	Method
SLR from Baseline SLR at each time point	Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)	Straight Leg Raise test(SLR) The straight leg raise(SLR)is a test done during a physical examination to determine whether a patient with low back pain has an underlying herniated disc, often located at L5 (fifth lumbar spinal nerve).; If the patient experiences sciatic pain when the straight leg is at an angle of between 30 and 70 degrees, then the test is positive and a herniated disk is a possible cause of the pain.\[3\] A negative test suggests a likely different cause for back pain.
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	EuroQol-5 Dimension(EQ-5D) EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
Lumbar ROM from Baseline Lumbar ROM at each time point	Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)	Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation) Pain upon movement in lumbar range of motion (ROM) will be assessed.
AE	up to 14 weeks after baseline	Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
NRS change from Baseline NRS at each timepoint	Baseline (admission), 2 weeks after baseline, 6 months 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 each timepoint	Baseline (admission), 2 weeks after baseline, 6 months 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.

Trial Locations

Locations (4)

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Korea, Republic of

Haeundae Jaseng Hospital of Korean Medicine; 🇰🇷 Busan, Korea, Republic of