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Active, Not Recruiting

NCT Number: NCT03959098

Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neck Pain Bone Diseases Cervical Radiculopathy Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Spinal Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: 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).

Other names: 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.

Primary outcomes

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

    Time frame: Time Frame: Change from baseline to 4 months

    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)

Secondary outcomes

  1. Visual analogue scale (VAS) of neck pain

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

    Neck pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)

  2. Visual analogue scale (VAS) of radiating arm pain

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

    Radiating arm pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)

  3. Neck Disability Index (NDI)

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

    Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 50 (worse outcome)

  4. Patient Global Impression of Change (PGIC)

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

    Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)

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

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

    Health-related quality of life questionnaire. Total score range: 11111 (better outcome) to 55555 (worse outcome)

  6. Type and frequency of other intervention(s)

    Time frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

    Use of any other additional intervention(s) other than the integrative Korean medicine treatment administered by the attending physician (start date of treatment, end date of treatment, name of treatment, number of treatment sessions received, and other comments)

  7. Physical examination

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

    Cervical physical examination

  8. Type and frequency of adverse reaction(s)

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

    Safety

  9. Numeric rating scale (NRS) of Neck pain

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

    Neck pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)

  10. Numeric rating scale (NRS) of radiating arm pain

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

    Radiating arm pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)

  11. SF-36

    Time frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  12. EQ-VAS

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

    The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy

Important dates

Study start
2019
Primary completion
2022
Study completion
2027
First posted
May 22, 2019
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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