Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation
- Conditions
- Neck PainCervical RadiculopathyIntervertebral Disc Displacement
- Registration Number
- NCT03959098
- Lead Sponsor
- 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
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain 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
Name Time Method Visual analogue scale (VAS) 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 100 (worse outcome)
Type and frequency of other intervention(s) 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)
Type and frequency of adverse reaction(s) Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Safety
Numeric rating scale (NRS) of Neck pain 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)
Visual analogue scale (VAS) 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 100 (worse outcome)
EuroQol 5-dimensions 5-levels (EQ-5D-5L) 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)
Physical examination Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Cervical physical examination
EQ-VAS [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'.
Neck Disability Index (NDI) 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: 8, 16, 20, 24 weeks, 1, 3, 5 years Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)
Numeric rating scale (NRS) of radiating arm pain 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 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.
Trial Locations
- Locations (1)
Jaseng Medical Foundation
🇰🇷Seoul, Korea, Republic of