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出境医 / 临床实验 / Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

Study Description
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
Study Design
Layout table for study information
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
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024
Arms and Interventions
Outcome Measures
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.

  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'.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date January 22, 2021
Actual Study Start Date June 24, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 20, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Physical examination [ Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years ]
    Cervical physical examination
  • Type and frequency of adverse reaction(s) [ Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years ]
    Safety
  • 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)
  • 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)
  • 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.
  • 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'.
Original Secondary Outcome Measures
 (submitted: May 20, 2019)
  • 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)
  • 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)
  • 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)
  • Northwick Park Neck Pain Questionnaire (NPQ) [ Time Frame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years ]
    Measures the neck pain and the consequent patient disabilities. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 36 (worse outcome)
  • 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)
  • 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)
  • Use 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)
  • Physical examination [ Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years ]
    Cervical physical examination
  • Adverse reaction [ Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years ]
    Safety
  • 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)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation
Official Title Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy
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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with symptoms of neck pain or radiating arm pain alongside cervical radiculopathy symptoms
Condition
  • Neck Pain
  • Cervical Radiculopathy
  • Intervertebral Disc Displacement
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: In-Hyuk Ha, KMD, Ph.D +82-2-2222-2740 hanihata@gmail.com
Contact: Taewoon Min, KMD +82-2-2222-2749 ka2522@naver.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959098
Other Study ID Numbers JS-CT-2019-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party In-Hyuk Ha, KMD, Jaseng Medical Foundation
Study Sponsor Jaseng Medical Foundation
Collaborators Not Provided
Investigators
Principal Investigator: 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
PRS Account Jaseng Medical Foundation
Verification Date January 2021