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Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

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ClinicalTrials.gov Identifier: NCT03959098
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, KMD, Jaseng Medical Foundation

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

Condition or disease Intervention/treatment
Neck Pain Cervical Radiculopathy Intervertebral Disc Displacement Drug: Herbal medicine Procedure: Chuna manual medicine Procedure: Bee venom pharmacopuncture Procedure: Pharmacopuncture Procedure: Acupuncture Procedure: Electroacupuncture Procedure: Cupping Procedure: Other intervention(s)

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

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: 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.
    Other Name: Traditional herbal medicine
  • Procedure: 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.
    Other Name: Chuna manipulation
  • 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).
    Other Name: Bee venom acupuncture
  • 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.
  • Procedure: Acupuncture
    Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
  • Procedure: Electroacupuncture
    Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
  • Procedure: Cupping
    Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptoms of neck pain or radiating arm pain alongside cervical radiculopathy symptoms
Criteria

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 6 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959098


Contacts
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Contact: In-Hyuk Ha, KMD, Ph.D +82-2-2222-2740 hanihata@gmail.com
Contact: Su-Bin HAN, KMD +82-2-2222-2755 suebin100@jaseng.co.kr

Locations
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Korea, Republic of
Jaseng Medical Foundation Not yet recruiting
Seoul, Korea, Republic of
Contact: In-Hyuk Ha, KMD    +82-2-3218-2188    hanihata@gmail.com   
Principal Investigator: Ji-yeon Seo, KMD         
Principal Investigator: Hyun-Woo Cho, KMD         
Principal Investigator: Min-young Kim, KMD         
Principal Investigator: Won-Yil Ko, KMD         
Sponsors and Collaborators
Jaseng Medical Foundation
Investigators
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Principal Investigator: Won-Il Ko, KMD Jaseng Hospital of Korean Medicine
Principal Investigator: Min-young 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

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Responsible Party: In-Hyuk Ha, KMD, K.M.D, Rehabilitation Medicine Specialist, Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT03959098     History of Changes
Other Study ID Numbers: JS-CT-2019-02
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by In-Hyuk Ha, KMD, Jaseng Medical Foundation:
Korean Medicine
Effectiveness
Neck Pain

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