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NCT Number: NCT01526031

Bee Venom Acupuncture for the Treatment of Frozen 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.

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Key information

Conditions

Frozen Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1:10,000 bee venom (BV) acupuncture

Procedure

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) acupuncture

Procedure

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)

Normal Saline Injection

Procedure

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)

physiotherapy

Procedure

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

Primary outcomes

  1. the Shoulder Pain and Disability Index (SPADI)

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

Secondary outcomes

  1. Visual Analogue Scale (VAS) for pain intensity

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

  2. passive Range of Motion (pROM)

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

    The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Kyung Hee University Hospital at Gangdong

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2012
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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