Purpose^[1]

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.

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

Study Design:

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Official Title:

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

Primary Outcome Measures: •the Shoulder Pain and Disability Index (SPADI) [ Time Frame: Changes from baseline in SPADI at 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures: •Visual Analogue Scale (VAS) for pain intensity [ Time Frame: Changes from baseline in VAS at 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]

•passive Range of Motion (pROM) [ Time Frame: Changes from baseline in pROM at 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]
The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.

References

1. ^{^} Purpose (www.clinicaltrials.gov)