Bee Venom Acupuncture for the Treatment of Frozen Shoulder

Kyung Hee University

Status and phase: Completed; Phase 2

Conditions: Frozen Shoulder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01526031

KHNMC-OH-IRB 2009-013

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 3 patient groups, including a placebo group

BV1

Experimental group

Description:

1:10,000 bee venom (BV) acupuncture plus physiotherapy

Treatment:

Procedure: 1:10,000 bee venom (BV) acupuncture

Procedure: physiotherapy

BV2

Experimental group

Description:

1:30,000 bee venom (BV) acupuncture plus physiotherapy

Treatment:

Procedure: 1:30,000 bee venom (BV) acupuncture

Procedure: physiotherapy

NS

Placebo Comparator group

Description:

Normal saline injection plus physiotherapy

Treatment:

Procedure: physiotherapy

Procedure: normal saline injection