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Bee Venom Acupuncture for the Treatment of Frozen Shoulder

This study has been completed.
Sponsor:
Collaborator:
Kyung Hee University Gangdong Hospital
Information provided by (Responsible Party):
Yonghyeon Baek, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01526031
First received: February 1, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Frozen Shoulder
 Procedure: 1:10,000 bee venom (BV) acupuncture
Procedure: 1:30,000 bee venom (BV) acupuncture
Procedure: normal saline injection
Procedure: physiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • the Shoulder Pain and Disability Index (SPADI) [ Time Frame: Changes from baseline in SPADI at 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analogue Scale (VAS) for pain intensity [ Time Frame: Changes from baseline in VAS at 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • passive Range of Motion (pROM) [ Time Frame: Changes from baseline in pROM at 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]
    The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.


Enrollment: 68
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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)
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
Placebo Comparator: NS
Normal saline injection plus physiotherapy
 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)
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526031

Locations
Korea, Republic of
Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Kyunghee University Medical Center
Kyung Hee University Gangdong Hospital
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
  More Information

No publications provided

Responsible Party: Yonghyeon Baek, Assisstant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01526031     History of Changes
Other Study ID Numbers: KHNMC-OH-IRB 2009-013
Study First Received: February 1, 2012
Last Updated: February 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
frozen shoulder
bee venom acupuncture

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013