Bee Venom Acupuncture for the Treatment of Frozen Shoulder

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder

Conditions
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Frozen Shoulder

Intervention / Treatment
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* Procedure: 1:10,000 bee venom (BV) acupuncture
* Procedure: 1:30,000 bee venom (BV) acupuncture
* Procedure: normal saline injection
* Procedure: physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of frozen shoulder by orthopedist 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: history of major shoulder injury or surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BV1<br>1:10,000 bee venom (BV) acupuncture plus physiotherapy | Procedure: 1:10,000 bee venom (BV) acupuncture<br>* 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)<br>Procedure: physiotherapy<br>* 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<br>|
| Experimental: BV2<br>1:30,000 bee venom (BV) acupuncture plus physiotherapy | Procedure: 1:30,000 bee venom (BV) acupuncture<br>* 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)<br>Procedure: physiotherapy<br>* 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<br>|
| Placebo Comparator: NS<br>Normal saline injection plus physiotherapy | Procedure: normal saline injection<br>* 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)<br>Procedure: physiotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Shoulder Pain and Disability Index (SPADI) |  | Changes from baseline in SPADI at 2, 4, 8, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | Changes from baseline in pROM at 2, 4, 8, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frozen shoulder, bee venom acupuncture