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This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments. The physician will decide specific location, type, and doses of pharmacopuncture therapy or conservative treatments according to each participants' disease conditions, respectively. The researcher will record concurrently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmacopuncture group | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
|
| conservative treatment group | Active Comparator | The physicians will choose the type and time of physical therapy and if needed, pharmacological treatment according to participants' conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacopuncture | Procedure | This is a pragmatic randomized controlled trials, so the physicians will choose pharmacopuncture treatment, including the type and doses, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) | NRS is a pain scale in which the patients 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'. The NRS of major painful site, which was chosen between low back and radiation pain in lower extremities, will be reported. | week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of low back pain and radiating pain | NRS is a pain scale in which the patients 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, 7, 8, 9, 10, 11, 12, 13, 25, 53 |
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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 |
|---|---|---|---|---|---|---|
| Dongguk University Bundang Oriental Hospital | Seongnam-si | Bundang-gu | 13601 | South Korea | ||
| Kyung Hee University Korean Medicine Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42099446 | Derived | Lee SW, Ahn YJ, Kim S, Lee Y, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. Pharmacopuncture therapy versus usual care for lumbar spinal stenosis: A randomized controlled trial. Integr Med Res. 2026 Sep;15(3Part A):101323. doi: 10.1016/j.imr.2026.101323. Epub 2026 Mar 28. | |
| 36176963 | Derived | Lee JY, Park KS, Kim S, Seo JY, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study. J Pain Res. 2022 Sep 23;15:2989-2996. doi: 10.2147/JPR.S382550. eCollection 2022. |
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|
| conservative treatments (including physiotherapy) | Procedure | This is a pragmatic randomized controlled trials, so the physicians will choose conservative treatment, including physiotherapy and pharmacological treatment, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently. |
|
| Visual analogue scale (VAS) of low back pain and radiating pain |
The patient indicates their pain severity from minimum 0 to maximum 100, which is a higher score means a worse outcome. VAS of low back pain and radiating leg pain will be reported. |
| week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53 |
| Walking distance | Claudication-free walking distance and maximal walking distance will be evaluated. | week 1, 5, 9, 13, 25, 53 |
| Zurich Claudication Questionnaire (ZCQ) | ZCQ is a lumbar spinal stenosis-specific patient reported outcome, which evaluate the disease severity, functional scale and satisfaction at the treatment. | week 1, 5, 9, 13, 25, 53 |
| 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, 5, 9, 13, 25, 53 |
| 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 13, 25, 53 |
| 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, 13, 25, 53 |
| 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, 13, 25, 53 |
| Seoul |
| Dongdaemun-gu |
| 130-701 |
| South Korea |
| Kyung Hee University Korean Medicine Hospital at Gangdong | Seoul | Gangdong-gu | 05278 | South Korea |
| Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu | 135-896 | South Korea |
| Bucheon Jaseng Hospital of Korean Medicine | 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 |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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