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Neck PainNCT03959098

Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

An observational study of Neck Pain and Cervical Radiculopathy, run by Jaseng Medical Foundation at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 65 years
What is being tested?
Herbal medicine, Chuna manual medicine and Bee venom pharmacopuncture
How many people
120 participants
Where
1 siteSouth Korea
Study dates
24 Jun 2019to 1 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jaseng Medical Foundation

    Seoul

Other trials in South Korea

About this study

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

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

Read the detailed description

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

Being tested
Herbal medicine, Chuna manual medicine, Bee venom pharmacopuncture, Pharmacopuncture, Acupuncture
Keywords
Korean Medicine, Effectiveness, Neck Pain
Medical subject headings
Neck Pain, Radiculopathy, Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Herbal medicineDrug

    Also called Traditional 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.

  • Chuna manual medicineProcedure or surgery

    Also called Chuna manipulation

    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.

  • Bee venom pharmacopunctureProcedure or surgery

    Also called Bee venom acupuncture

    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).

  • PharmacopunctureProcedure or surgery

    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.

  • AcupunctureProcedure or surgery

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

  • ElectroacupunctureProcedure or surgery

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

  • CuppingProcedure or surgery

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

  • Other intervention(s)Procedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Time Frame: Change from baseline to 4 months

Secondary outcomes (12)

  1. Visual analogue scale (VAS) of neck pain

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

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

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

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

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

  3. Neck Disability Index (NDI)

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

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

  4. Patient Global Impression of Change (PGIC)

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

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

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

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

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

  6. Type and frequency of other intervention(s)

    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)

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

  7. Physical examination

    Cervical physical examination

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

  8. Type and frequency of adverse reaction(s)

    Safety

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

  9. Numeric rating scale (NRS) of Neck pain

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

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

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

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

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

  11. SF-36

    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.

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

  12. EQ-VAS

    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'.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start24 Jun 2019
  3. Primary completion28 Jan 2022
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03959098
Sponsor's protocol ID
JS-CT-2019-02
Status last verified
Dec 2025
First submitted
20 May 2019
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain and Cervical Radiculopathy, run by Jaseng Medical Foundation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain (time frame: Time Frame: Change from baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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