Bee Venom Acupuncture for the Treatment of Frozen Shoulder

NCT ID: NCT01526031

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Frozen Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BV1

1:10,000 bee venom (BV) acupuncture plus physiotherapy

Group Type EXPERIMENTAL

1:10,000 bee venom (BV) acupuncture

Intervention Type 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)

physiotherapy

Intervention Type 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

BV2

1:30,000 bee venom (BV) acupuncture plus physiotherapy

Group Type EXPERIMENTAL

1:30,000 bee venom (BV) acupuncture

Intervention Type 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)

physiotherapy

Intervention Type 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

NS

Normal saline injection plus physiotherapy

Group Type PLACEBO_COMPARATOR

normal saline injection

Intervention Type 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

Intervention Type 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

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yonghyeon Baek

Assisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yonghyeon Baek, OMD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong

Byung-Kwan Seo, OMD, Ph.D

Role: STUDY_DIRECTOR

Kyung Hee University Hospital at Gangdong

Locations

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Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KHNMC-OH-IRB 2009-013

Identifier Type: -

Identifier Source: org_study_id

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