Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study
- Conditions
- OPLLMedicine, Korean Traditional
- Registration Number
- NCT04446221
- Lead Sponsor
- Jaseng Medical Foundation
- Brief Summary
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Ossification of Posterior Longitudinal Ligament(OPLL) by observation inpatients treated with integrative Korean medicine.
This study is a prospective observational study. The subjects for study are patients diagnosed with OPLL and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2019.12.31.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Vernon-Mior Neck Disability Index (NDI), quality of life, and Patient Global Impression of Change (PGIC), etc.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- Patients diagnosed with OPLL by C spine X-ray or MRI or CT
- Paithents who was admitted to Jaseng hospital of Korean medicien.
- Patients have agreed to participate the study.
- Patient hospitalized under 3 days
- Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
- Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, fibromyalgia, rheumatoid arthritis, gout, and so on)
- Patients had cervical spinal surgery within 3 months
- Patients diagnosed with C spine fracture by C spine X-ray or MRI or CT
- Patients deemed unable to participate in the clinical research by other researchers
- Patients haven't agreed to participate the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Numeric rating scale (NRS) Finish survey by September 2020 NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) Finish survey by September 2020 PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Current symptoms survey Finish survey by September 2020 Pain, neurological problems, etc.
Vernon-Mior Neck Disability Index (NDI) Finish survey by September 2020 NDI is a 10-item questionnaire developed to evaluate the degree of disability for neck back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean NDI questionnaire
Spine surgery Finish survey by September 2020 The number of spinal surgery after discharge
Treatment after discharge survey Finish survey by September 2020 Treatment history in the last 3 month
The five level version of EuroQol-5 Dimension (EQ-5D) Finish survey by September 2020 EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used.
Satisfaction with integrative Korean medicine survey Finish survey by September 2020 Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.
Trial Locations
- Locations (1)
Jaseng Medical Foundation
🇰🇷Seoul, Korea, Republic of