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| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
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The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BV1 | Experimental | 1:10,000 bee venom (BV) acupuncture plus physiotherapy |
|
| BV2 | Experimental | 1:30,000 bee venom (BV) acupuncture plus physiotherapy |
|
| NS | Placebo Comparator | Normal saline injection plus physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1:10,000 bee venom (BV) acupuncture | Procedure | after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
|
| Measure | Description | Time Frame |
|---|---|---|
| the Shoulder Pain and Disability Index (SPADI) | Changes from baseline in SPADI at 2, 4, 8, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) for pain intensity | Changes from baseline in VAS at 2, 4, 8, 12 weeks | |
| passive Range of Motion (pROM) | The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yonghyeon Baek, OMD, Ph.D | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Byung-Kwan Seo, OMD, Ph.D | Kyung Hee University Hospital at Gangdong | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong | Seoul | 134-727 | South Korea |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D001514 | Bee Venoms |
| D015670 | Acupuncture Therapy |
| D000077330 | Saline Solution |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D001180 | Arthropod Venoms |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
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|
| 1:30,000 bee venom (BV) acupuncture | Procedure | after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
|
|
| normal saline injection | Procedure | after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
|
|
| physiotherapy | Procedure | Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
|
|
| Changes from baseline in pROM at 2, 4, 8, 12 weeks |
| D001685 |
| Biological Factors |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D012046 | Rehabilitation |