Bee Venom Acupuncture for the Treatment of Frozen Shoulder
NCT ID: NCT01526031
Last Updated: 2012-02-03
Study Results
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Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2010-01-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BV1
1:10,000 bee venom (BV) acupuncture plus physiotherapy
1:10,000 bee venom (BV) acupuncture
after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
* 1st visit : SC 0.4ml of 1:10,000 BV at 4 points (0.1ml for each points)
* 2nd visit : SC 0.6ml of 1:10,000 BV at 6 points (0.1ml for each points)
* 3rd visit : SC 0.8ml of 1:10,000 BV at 8 points (0.1ml for each points)
* 4th to 16th visit : SC 1.0ml of 1:10,000 BV at 10 points (0.1ml for each points)
physiotherapy
Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
* transcutaneous electrical nerve stimulation (TENS) for 15 minutes
* transcutaneous infrared thermotherapy (TDP) for 15 minutes
* manual physical therapy for 15 minutes
* simple home exercise program
BV2
1:30,000 bee venom (BV) acupuncture plus physiotherapy
1:30,000 bee venom (BV) acupuncture
after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
* 1st visit : SC 0.4ml of 1:30,000 BV at 4 points (0.1ml for each points)
* 2nd visit : SC 0.6ml of 1:30,000 BV at 6 points (0.1ml for each points)
* 3rd visit : SC 0.8ml of 1:30,000 BV at 8 points (0.1ml for each points)
* 4th to 16th visit : SC 1.0ml of 1:30,000 BV at 10 points (0.1ml for each points)
physiotherapy
Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
* transcutaneous electrical nerve stimulation (TENS) for 15 minutes
* transcutaneous infrared thermotherapy (TDP) for 15 minutes
* manual physical therapy for 15 minutes
* simple home exercise program
NS
Normal saline injection plus physiotherapy
normal saline injection
after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
* 1st visit : SC 0.4ml of normal saline at 4 points (0.1ml for each points)
* 2nd visit : SC 0.6ml of normal saline at 6 points (0.1ml for each points)
* 3rd visit : SC 0.8ml of normal saline at 8 points (0.1ml for each points)
* 4th to 16th visit : SC 1.0ml of normal saline at 10 points (0.1ml for each points)
physiotherapy
Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
* transcutaneous electrical nerve stimulation (TENS) for 15 minutes
* transcutaneous infrared thermotherapy (TDP) for 15 minutes
* manual physical therapy for 15 minutes
* simple home exercise program
Interventions
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1:10,000 bee venom (BV) acupuncture
after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
* 1st visit : SC 0.4ml of 1:10,000 BV at 4 points (0.1ml for each points)
* 2nd visit : SC 0.6ml of 1:10,000 BV at 6 points (0.1ml for each points)
* 3rd visit : SC 0.8ml of 1:10,000 BV at 8 points (0.1ml for each points)
* 4th to 16th visit : SC 1.0ml of 1:10,000 BV at 10 points (0.1ml for each points)
1:30,000 bee venom (BV) acupuncture
after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
* 1st visit : SC 0.4ml of 1:30,000 BV at 4 points (0.1ml for each points)
* 2nd visit : SC 0.6ml of 1:30,000 BV at 6 points (0.1ml for each points)
* 3rd visit : SC 0.8ml of 1:30,000 BV at 8 points (0.1ml for each points)
* 4th to 16th visit : SC 1.0ml of 1:30,000 BV at 10 points (0.1ml for each points)
normal saline injection
after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
* 1st visit : SC 0.4ml of normal saline at 4 points (0.1ml for each points)
* 2nd visit : SC 0.6ml of normal saline at 6 points (0.1ml for each points)
* 3rd visit : SC 0.8ml of normal saline at 8 points (0.1ml for each points)
* 4th to 16th visit : SC 1.0ml of normal saline at 10 points (0.1ml for each points)
physiotherapy
Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
* transcutaneous electrical nerve stimulation (TENS) for 15 minutes
* transcutaneous infrared thermotherapy (TDP) for 15 minutes
* manual physical therapy for 15 minutes
* simple home exercise program
Eligibility Criteria
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Inclusion Criteria
* Must have shoulder pain of more than VAS 5 over 1 month and under 12 months
* Marked limitation of active and/or passive motion range in one shoulder
Exclusion Criteria
* other musculoskeletal pain
* cervical neuropathy, paralysis, neurological disorder
* hypersensitivity reactions by bee venom skin test
* renal or hepatic disorders, hematologic diseases, cancer, mental disorders, inflammatory or infectious disorders
18 Years
70 Years
ALL
No
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
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Yonghyeon Baek
Assisstant Professor
Principal Investigators
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Yonghyeon Baek, OMD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong
Byung-Kwan Seo, OMD, Ph.D
Role: STUDY_DIRECTOR
Kyung Hee University Hospital at Gangdong
Locations
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Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Countries
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Other Identifiers
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KHNMC-OH-IRB 2009-013
Identifier Type: -
Identifier Source: org_study_id
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