Observational study on effectiveness and safety of integrative Korean medicine treatment for cervical disc herniation with radiculopathy
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0004158
- Lead Sponsor
- Jaseng Hospital of Korean Medicine
- Brief Summary
Not available
- Detailed Description
Not available
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 6 month before
1 Patients with cervical radiculopathy symptoms of one or both side of arms
2 Patients diagnosed with cervical disc herniation with over protrusion
degree of prolapsed inter-vertebral disc assessed on MRI
3 Patients with plans of receiving Korean medicine treatment for cervical disc
herniation for =2 months
4 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)
1 Pregnant patients or patients planning pregnancy
2 Patients with serious psychological disorders
3 Patients unable to fill out study participation consent form
4 Patients deemed unsuitable for study participation as assessed by the researchers
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umeric Rating Scale (NRS)
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) of Neck pain;Numeric Rating Scale (NRS) of neck pain;Numeric Rating Scale (NRS) of radiating arm pain;Visual Analogue Scale (VAS) of radiating arm pain;Neck Disability Index (NDI);Physical examination;Adverse events;Patient Global Impression of Change (PGIC);EuroQol-5 Dimension (EQ-5D);Type and frequency of other intervention;EQ-VAS;Drug Consumption