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This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmacopuncture therapy | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
|
| physical therapy | Active Comparator | The physicians will choose the type and time of physical therapy according to participants' conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacopuncture therapy | Procedure | This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) of low back pain | Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome. | Change from baseline VAS at week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 10, 16 |
| Numeric rating scale (NRS) of low back pain and leg radiating pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha, Ph.D | Jaseng Medical Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu | 135-896 | South Korea | ||
| Bucheon Jaseng Hospital of Korean Medicine |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| physical therapy | Procedure | This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions. |
|
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. |
| Week 1, 2, 3, 4, 5, 6, 10, 16 |
| Oswestry Disability Index (ODI) | ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome). | Week 1, 6, 10, 16 |
| Korean version of the Roland-Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability). | Week 1, 6, 10, 16 |
| 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, no change; 5, minimally worse; 6, much worse; or 7, very much worse.) | Week 6, 10, 16 |
| 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, 6, 10, 16 |
| 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, 6, 10, 16 |
| Bucheon-si |
| Gyeonggi Province |
| 14598 |
| South Korea |
| Haeundae Jaseng Hospital of Korean Medicine | Busan | South Korea |
| Daejeon Jaseng Hospital of Korean Medicine | Daejeon | 35262 | South Korea |