Bee Venom Acupuncture for the Treatment of Frozen Shoulder

Kyunghee University Medical Center68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Frozen Shoulder

Interventions

1:10,000 bee venom (BV) acupuncturePROCEDURE

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) acupuncturePROCEDURE

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Outcomes

Primary Outcomes

the Shoulder Pain and Disability Index (SPADI)

Time frame: Changes from baseline in SPADI at 2, 4, 8, 12 weeks

Secondary Outcomes

Visual Analogue Scale (VAS) for pain intensity

Time frame: 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.

Time frame: Changes from baseline in pROM at 2, 4, 8, 12 weeks

Data from ClinicalTrials.gov

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