Long Term Follow-up of Cervical Myelopathy Inpatients Treated With Integrated Complementary and Alternative Medicine
Study Details
Study Description
Brief Summary
Model of this study is a combined both retrospective chart review and follow up survey. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in cervical myelopathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Cervical myelopathy is known as Its symptoms are progressively worsened, and there are only a small amount of positive outcomes other than surgery.
However, as with other spinal and nerve disorders, non-surgical treatments are getting more attention in terms of patient safety, and because they provide patients with more choice in treatment than in terms of surgical treatment, they can provide closer approach to patient-centered care.
Physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of cervical myelopathy by using Korean medicine treatment so far has its weak level. Therefore, it is expected that this study will demonstrate the efficacy of the treatment of cervical myelopathy in Korean medicine treatment and will further pave the way for non-surgical treatment of spinal myelopathy.
Therefore, The investigators conducted observational trial to analyze the effectiveness of Korean medicine treatment in spinal myelopathy. Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data.
The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. The questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.
Study Design
Outcome Measures
Primary Outcome Measures
- Cervical spinal surgery status after discharge [Finish survey by Jan 2020]
The investigators will survey whether the patients had surgery after discharging from 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital.
Secondary Outcome Measures
- Cervical spinal surgery recommendations before hospitalization [Finish survey by Jan 2020]
The investigators will survey whether the patients were recommended before hospitalization in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital).
- Symptom reoccurrence experience lasting for more than a month after treatment is closed [Finish survey by Jan 2020]
The investigators will survey whether the patients experienced symptom reoccurrence lasting for more than a month after treatment is closed after hospitalization in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital).
- Whether symptoms that are uncomfortable in daily life exists [Finish survey by Jan 2020]
The investigators will survey whether the patients feel uncomfortable daily life symptoms after hospitalization in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital).
- Whether currently being treated for neck or upper extremity symptoms [Finish survey by Jan 2020]
The investigators will survey whether the patients are currently being treated for neck or upper extremity symptoms
- Numeric Rating Scale of Neck and upper extremity pain [Finish survey by Jan 2020]
The investigators will survey Numeric Rating Scale(NRS) scores of neck and upper extremity at the time of the disease and current symptoms. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
- Neck Disability Index [Finish survey by Jan 2020]
The investigators will survey current Neck Disability Index (NDI) scores. NDI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
- EuroQol 5-dimensions 5-levels [Finish survey by Jan 2020]
The investigators will survey current EuroQol 5-dimensions 5-levels scores. The EQ-5D-5L is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems).
- Patient Global Impression of Change [Finish survey by Jan 2020]
The investigators will survey current Patient Global Impression of Change scores. The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who had been hospitalized with symptoms of neurological defects such as muscle weakness in the upper extremity or sensory abnormalities, or impaired walking due to weakness in the lower extremity at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Incheon Jaseng Korean Medicine Hospital from Jan 2011 to Oct 2018.
-
Patients diagnosed with 'Cervical myelopathy' finding and able to check the pressure and damage of the spinal cord (high signal shading) of the EMR imaging (T2-weighted MRI scan of C-spine)
-
Patients who agreed voluntarily to participate in verbal consent
Exclusion Criteria:
-
Patients whose chief complaint is not cervical myelopathy or who do not have the neurological defect of upper extremity or lower extremity
-
If the cause of the neurological defect of the upper and lower extremities is not caused by the spine or tissue
-
Patients who do not agree to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haeundae Jaseng Hospital of Korean Medicine | Busan | Korea, Republic of | 48102 |
Sponsors and Collaborators
- Jaseng Medical Foundation
Investigators
- Study Chair: In-Hyuk Ha, Jaseng Medical Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JS-CT-2019-05