Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

NCT03959098 | Active Not Recruiting

• 1 other identifier: JS-CT-2019-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neck Pain; Cervical Radiculopathy; Intervertebral Disc Displacement

Keywords

Korean Medicine; Effectiveness; Neck Pain

Outcome Measures

Primary Outcomes (1)

• Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain

  Change from higher score at baseline out of neck pain or radiating arm pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome) Total score range: -10 (worse outcome) to 10 (better outcome)

  Time Frame: Change from baseline to 4 months

Secondary Outcomes (12)

• Visual analogue scale (VAS) of neck pain

  Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

• Visual analogue scale (VAS) of radiating arm pain

  Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

• Neck Disability Index (NDI)

  Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

• Patient Global Impression of Change (PGIC)

  Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years

• EuroQol 5-dimensions 5-levels (EQ-5D-5L)

  Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

Interventions

Herbal medicine DRUG

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.

Also known as: Traditional herbal medicine

Chuna manual medicine PROCEDURE

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.

Also known as: Chuna manipulation

Bee venom pharmacopuncture PROCEDURE

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).

Also known as: Bee venom acupuncture

Pharmacopuncture PROCEDURE

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.

Acupuncture PROCEDURE

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

Electroacupuncture PROCEDURE

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

Cupping PROCEDURE

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

Other intervention(s) PROCEDURE

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.

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of neck pain or radiating arm pain alongside cervical radiculopathy symptoms

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Neck Pain; Radiculopathy; Intervertebral Disc Displacement

Interventions

Phytotherapy; Acupuncture Therapy; Electroacupuncture; Cupping Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Won-Il Ko, KMD

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

• Sun-A Kim, KMD

  Daejeon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

• Hyun-Woo Cho, KMD

  Haeundae Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

• Ji-Yun Seo, KMD

  Bucheon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: K.M.D, Rehabilitation Medicine Specialist

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: June 24, 2019
• Primary Completion: January 28, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)