Clinical trial NCT04173923: Long Term Follow-up of Cervical Myelopathy Inpatients Treated With Integrated Complementary and Alternative Medicine
Official title: Long Term Follow-up of Cervical Myelopathy Inpatients Treated With Integrated Complementary and Alternative Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Myelopathy
Keywords: Cervical Myelopathy
Korean medicine treatment
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who ended up the hospitalization and treatment in Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, Incheon Jaseng Korean Medicine Hospital

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.

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.

Eligibility 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

Primary outcomes:
measure: Cervical spinal surgery status after discharge
timeFrame: Finish survey by Jan 2020
Secondary outcomes:
measure: Cervical spinal surgery recommendations before hospitalization
timeFrame: Finish survey by Jan 2020
measure: Symptom reoccurrence experience lasting for more than a month after treatment is closed
timeFrame: Finish survey by Jan 2020
measure: Whether symptoms that are uncomfortable in daily life exists
timeFrame: Finish survey by Jan 2020
measure: Whether currently being treated for neck or upper extremity symptoms
timeFrame: Finish survey by Jan 2020
measure: Numeric Rating Scale of Neck and upper extremity pain
timeFrame: Finish survey by Jan 2020
measure: Neck Disability Index
timeFrame: Finish survey by Jan 2020
measure: EuroQol 5-dimensions 5-levels
timeFrame: Finish survey by Jan 2020
measure: Patient Global Impression of Change
timeFrame: Finish survey by Jan 2020
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha
role: STUDY_CHAIR
References: