Bee Venom Acupuncture for the Treatment of Frozen Shoulder

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

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 Overview

• Status: Completed
• Conditions: Frozen Shoulder
• Intervention / Treatment: Procedure: 1:10,000 bee venom (BV) acupuncture; Procedure: physiotherapy; Procedure: 1:30,000 bee venom (BV) acupuncture; Procedure: normal saline injection

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 134-727
    • Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BV1; 1:10,000 bee venom (BV) acupuncture plus physiotherapy	Procedure: 1:10,000 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); Procedure: physiotherapy; 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
EXPERIMENTAL: BV2; 1:30,000 bee venom (BV) acupuncture plus physiotherapy	Procedure: physiotherapy; 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; Procedure: 1:30,000 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)
PLACEBO_COMPARATOR: NS; Normal saline injection plus physiotherapy	Procedure: physiotherapy; 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; Procedure: normal 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) for pain intensity		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.	Changes from baseline in pROM at 2, 4, 8, 12 weeks

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Kyung Hee University Hospital at Gangdong
• Investigators: Principal Investigator: Yonghyeon Baek, OMD, Ph.D, Kyung Hee University Hospital at Gangdong; Study Director: Byung-Kwan Seo, OMD, Ph.D, Kyung Hee University Hospital at Gangdong

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (ESTIMATE): February 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: frozen shoulder; bee venom acupuncture
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: KHNMC-OH-IRB 2009-013