Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Shoulder mobility on the Shoulder ROM |
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer. |
At within 2 weeks |
|
Secondary |
Numeric Rating Scale(NRS) of shoulder pain |
The extent of shoulder pain and discomfort was assessed using NRS. 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 shoulder pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. |
At screening, baseline, 2 weeks, 3 months, and through study completion, an average of 3 month |
|
Secondary |
Visual Analogue Scale (VAS) of shoulder pain |
VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end. |
At screening, baseline, 2 weeks and through study completion, an average of 3 month |
|
Secondary |
Shoulder Pain and Disability Index(SPADI) questionnaire of shoulder pain and disability |
SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. |
At baseline, 2 weeks, 3 months |
|
Secondary |
Patient Global Impression of Change (PGIC) |
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. |
At baseline, 2 weeks, 3 months |
|
Secondary |
EuroQol 5-Dimension (EQ-5D-5L) |
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). In this study, The investigators will use the Korean version of the EQ-5D-5L, which has been demonstrated to be valid. |
At baseline, 2 weeks, 3 months |
|
Secondary |
Adverse events(AE) |
Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs. |
Through study completion, an average of 3 month |
|
Secondary |
Shoulder mobility on the Shoulder ROM |
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer. |
At screening, baseline, 2 weeks, 3 months and through study completion, an average of 3 month |
|