Bee Venom Acupuncture for the Treatment of Frozen Shoulder

NCT01526031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-02-03

No results posted yet for this study

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.

Conditions

  • Frozen Shoulder

Interventions

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

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

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

Sponsors & Collaborators

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER
  • Kyunghee University Medical Center

    lead OTHER

Principal Investigators

  • Yonghyeon Baek, OMD, Ph.D · Kyung Hee University Hospital at Gangdong

  • Byung-Kwan Seo, OMD, Ph.D · Kyung Hee University Hospital at Gangdong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526031 on ClinicalTrials.gov