Bee Venom Acupuncture for the Treatment of Frozen Shoulder

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526031

Enrollment

Registered

2012-02-03

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2012-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen Shoulder

Keywords

frozen shoulder, bee venom acupuncture

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.

Interventions

PROCEDURE1:10,000 bee venom (BV) acupuncture

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)

PROCEDURE1:30,000 bee venom (BV) acupuncture

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)

PROCEDUREnormal saline injection

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)

PROCEDUREphysiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026