Bee Venom Acupuncture for the Treatment of Frozen Shoulder

Phase 2

Completed

• Conditions: Frozen Shoulder
• Interventions: Procedure: physiotherapy; Procedure: normal saline injection

• Registration Number: NCT01526031
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-02
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Last Update Submitted: 2012-02-01
• Study First Posted: 2012-02-03
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BV1	physiotherapy	1:10,000 bee venom (BV) acupuncture plus physiotherapy
BV2	physiotherapy	1:30,000 bee venom (BV) acupuncture plus physiotherapy
NS	normal saline injection	Normal saline injection plus physiotherapy
NS	physiotherapy	Normal saline injection plus physiotherapy

Primary Outcome Measures

Name	Time	Method
the Shoulder Pain and Disability Index (SPADI)	Changes from baseline in SPADI at 2, 4, 8, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) for pain intensity	Changes from baseline in VAS at 2, 4, 8, 12 weeks
passive Range of Motion (pROM)	Changes from baseline in pROM at 2, 4, 8, 12 weeks	The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.

Trial Locations

Locations (1)

Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of