Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Area of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view |
Comparison of disc herniation in MRI between the baseline and post-treatment. |
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months |
|
| Secondary |
Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view |
Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view will be classified into 5 levels according to the method suggested by Pfirrmann et al. |
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months |
|
| Secondary |
Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view |
Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view will be divided into 4 levels: protrusion, extrusion, sequestration, and migration |
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months |
|
| Secondary |
Level of herniated disc migration in patients with disc migration at disc level most relevant to patient symptoms on MR sagittal and axial view |
Level of herniated disc migration in patients with disc migration will be categorized into 3 levels in accordance with the Komori classification |
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months |
|
| Secondary |
Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view |
Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view will be classified into Modic types 0, 1, 2, and 3 |
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months |
|
| Secondary |
Modic type change location with regard to disc level most relevant to patient symptoms on MR sagittal and axial view |
Location of modic type change at the vertebrae adjacent to the herniated disc is classified by whether it is above, below, neither above nor below, or both above and below the disc level most relevant to patient symptoms on MR sagittal and axial view |
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months |
|
| Secondary |
Pain NRS at site of chief complaint |
Low back pain NRS or neck pain NRS |
Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Radiating pain NRS associated with site of chief complaint |
Radiating leg pain NRS or radiating arm pain NRS |
Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Whether or not patient has been recommended for surgery regarding pain at site of chief complaint |
Whether or not patient has been recommended for surgery regarding pain at site of chief complaint will be recorded dichotomously |
Post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Whether or not pain has recurred for 1 month or longer at site of chief complaint |
Whether or not low back pain, radiating leg pain, neck pain or radiating arm pain has recurred at site of chief complaint will be recorded dichotomously |
Post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint |
Type of treatment received, if any, for pain recurrence at site of chief complaint out of Korean medicine treatment, conventional nonsurgical treatment, or surgery will be recorded |
Post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset |
Whether or not patient is aware of possible spontaneous disc resorption at site of chief complaint will be recorded dichotomously |
Post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Type of treatment patient would recommend to others as primary care |
Type of treatment patient would recommend to others out of surgical and nonsurgical treatment will be recorded |
Post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Satisfaction with integrative Korean medicine treatment |
Satisfaction with integrative Korean medicine treatment will be recorded using a 5-point Likert scale: very dissatisfied, dissatisfied, slightly satisfied, satisfied, very satisfied |
Post-treatment follow-up phone interview at average of 3 years |
|
| Secondary |
Korean medicine treatment method perceived to be most effective |
Korean medicine treatment method perceived to be most effective out of herbal medicine, pharmacopuncture/bee venom pharmacopuncture, acupuncture, and Chuna manipulation will be recorded |
Post-treatment follow-up phone interview at average of 3 years |
|
