Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
NCT ID: NCT03750591
Last Updated: 2020-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2018-03-31
2019-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
Herbal medicine
Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Chuna manual therapy
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
Chuna manipulation will be administered at the physician's discretion.
Bee venom pharmacopuncture
Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test.
Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
Pharmacopuncture
Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
Interventions
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Herbal medicine
Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Chuna manual therapy
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
Chuna manipulation will be administered at the physician's discretion.
Bee venom pharmacopuncture
Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test.
Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
Pharmacopuncture
Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
70 Years
ALL
No
Sponsors
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Jaseng Medical Foundation
OTHER
Responsible Party
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In-Hyuk Ha, KMD
Director
Principal Investigators
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HYUN WOO CHO, PhD
Role: PRINCIPAL_INVESTIGATOR
Haeundae Jaseng Hospital of Korean Medicine
Locations
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Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, South Korea
Haeundae Jaseng Hospital of Korean Medicine
Busan, , South Korea
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, , South Korea
Jaseng Hospital of Korean Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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JS-CT-2017-05-1
Identifier Type: -
Identifier Source: org_study_id
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