Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korea Institute of Oriental Medicine | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KM non-pharmacological treatment group | Experimental | Non-pharmacological treatment including Korean medicine will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. |
|
| Pharmacological treatment group | Active Comparator | Pharmacological treatment will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KM non-pharmacological treatment group | Other | This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of radiating pain in lower extremities | NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'. | week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of radiating pain in lower extremities | NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'. | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyoung Sun Park, KMD,Ph.D | Jaseng Hospital of Korean Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Hospital of Korean Medicine | Seoul | 06110 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pharmacological treatment group | Other | This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject. |
|
| Numeric rating scale (NRS) of low-back pain |
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'. |
| week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 |
| Visual analogue scale (VAS) of leg radiating pain | Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome. | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 |
| Visual analogue scale (VAS) of low-back pain | Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome. | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 |
| Oswestry Disability Index (ODI) | ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome) | week 1, 5, 9, 14, 27 |
| Fear-Avoidance Beliefs Questionnaire (FABQ) | FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain | week 1, 9, 14, 27 |
| Patient Global Impression of Change (PGIC) | Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.) | week 9, 14, 27 |
| Short Form-12 Health Survey version 2 (SF-12 v2) | The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life. | week 1, 5, 9, 14, 27 |
| EuroQol-5 Dimension (EQ-5D-5L) | 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) | week 1, 5, 9, 14, 27 |