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| Name | Class |
|---|---|
| Korea Institute of Oriental Medicine | OTHER_GOV |
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This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.
This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 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 type and volume of pharmacopuncture and physical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacopuncture therapy | Experimental | Pharmacopuncture will be administered to the subjects in the pharmacopuncture therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions. |
|
| Physical therapy | Active Comparator | Physical therapy will be applied to the subjects in the physical therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacopuncture therapy | Procedure | The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and dosage will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of low-back pain | 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 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of low-back pain | 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, 13, 25 |
| Numeric rating scale (NRS) of radiating pain in lower extremities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha, KMD,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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41497196 | Derived | Lee YS, Kim SJ, Park KS, Lee YJ, Yang C, Han CH, Ha IH. A cost-utility analysis of pharmacopuncture versus physiotherapy for chronic low back pain: A multicenter, pragmatic randomized controlled trial. Integr Med Res. 2025 Dec;14(4):101210. doi: 10.1016/j.imr.2025.101210. Epub 2025 Aug 5. | |
| 36072909 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2021 |
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|
| physical therapy | Procedure | The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and body part will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively. |
|
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, 13, 25 |
| 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, 13, 25 |
| 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, 13, 25 |
| 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, 13, 25 |
| 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, 13, 25 |
| 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, 13, 25 |
| 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, 13, 25 |
| 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, 13, 25 |
| Bucheon-si |
| Gyeonggi Province |
| 14598 |
| South Korea |
| Haeundae Jaseng Hospital of Korean Medicine | Busan | 48102 | South Korea |
| Daejeon Jaseng Hospital of Korean Medicine | Daejeon | 35262 | South Korea |
| Park KS, Kim S, Seo JY, Cho H, Lee JY, Lee YJ, Lee J, Kim MJ, Choi YE, Yang CS, Han CH, Ha IH. Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Protocol for a Pragmatic Randomized Controlled Trial. J Pain Res. 2022 Sep 1;15:2629-2639. doi: 10.2147/JPR.S375231. eCollection 2022. |
| Dec 17, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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