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Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

NCT ID: NCT03959098

Last Updated: 2025-12-17

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-24

Study Completion Date

2027-12-01

Brief Summary

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A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in cervical disc herniation patients with neck pain or cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, work loss and quality of life patient-reported outcomes

Detailed Description

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This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in cervical disc herniation patients with neck pain or cervical radiculitis diagnosed by cervical MRI and clinical symptoms including cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Bucheon, Daejeon, Haeundae) as assessed through of pain, functional disability, work loss, and quality of life patient-reported outcomes with a 5-year follow-up period

Conditions

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Neck Pain Cervical Radiculopathy Intervertebral Disc Displacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Herbal medicine

Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.

Intervention Type DRUG

Chuna manual medicine

Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine 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 manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.

Intervention Type PROCEDURE

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 usually 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, 26G x 1.5 syringe, hinchang medical co., Korea).

Intervention Type PROCEDURE

Pharmacopuncture

Pharmacopuncture consisting of select herbal ingredients will be dministered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.

Intervention Type PROCEDURE

Acupuncture

Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Intervention Type PROCEDURE

Electroacupuncture

Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Intervention Type PROCEDURE

Cupping

Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.

Intervention Type PROCEDURE

Other intervention(s)

Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.

Intervention Type PROCEDURE

Other Intervention Names

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Traditional herbal medicine Chuna manipulation Bee venom acupuncture

Eligibility Criteria

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Inclusion Criteria

* Patients with age between 19 years \~ 65 years
* Patients with one arm pain or both side arm pain or neck pain with intensity of NRS ≥6 which occurred less then 12 month before
* Patients with cervical radiculopathy symptoms of one or both side of arms
* Patients diagnosed with cervical disc herniation with over protrusion degree of prolapsed inter-vertebral disc assessed on MRI
* Patients with plans of receiving Korean medicine treatment for cervical disc herniation for ≥2 months
* Patients who have agreed to study participation

Exclusion Criteria

* Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
* Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause neck pain or radiating arm pain (e.g. spinal tumor, rheumatoid arthritis)
* Patients with medical history of cervical myelopathy which can cause neck pain or radiating arm pain
* Patients with medical history of surgery in relation with cervical disc herniation
* Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anticoagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
* Pregnant patients or patients planning pregnancy
* Patients with serious psychological disorders
* Patients unable to fill out study participation consent form
* Patients deemed unsuitable for study participation as assessed by the researchers
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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In-Hyuk Ha, KMD

K.M.D, Rehabilitation Medicine Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won-Il Ko, KMD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Hospital of Korean Medicine

Sun-A Kim, KMD

Role: PRINCIPAL_INVESTIGATOR

Daejeon Jaseng Hospital of Korean Medicine

Hyun-Woo Cho, KMD

Role: PRINCIPAL_INVESTIGATOR

Haeundae Jaseng Hospital of Korean Medicine

Ji-Yun Seo, KMD

Role: PRINCIPAL_INVESTIGATOR

Bucheon Jaseng Hospital of Korean Medicine

Locations

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Jaseng Medical Foundation

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JS-CT-2019-02

Identifier Type: -

Identifier Source: org_study_id