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Bee Venom Acupuncture for the Treatment of Frozen Shoulder

Primary Purpose

Frozen Shoulder

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
1:10,000 bee venom (BV) acupuncture
1:30,000 bee venom (BV) acupuncture
normal saline injection
physiotherapy
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring frozen shoulder, bee venom acupuncture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BV1

BV2

NS

Arm Description

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

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

Normal saline injection plus physiotherapy

Outcomes

Primary Outcome Measures

the Shoulder Pain and Disability Index (SPADI)

Secondary Outcome Measures

Visual Analogue Scale (VAS) for pain intensity
passive Range of Motion (pROM)
The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.

Full Information

First Posted
February 1, 2012
Last Updated
February 1, 2012
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT01526031
Brief Title
Bee Venom Acupuncture for the Treatment of Frozen Shoulder
Official Title
Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
frozen shoulder, bee venom acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BV1
Arm Type
Experimental
Arm Description
1:10,000 bee venom (BV) acupuncture plus physiotherapy
Arm Title
BV2
Arm Type
Experimental
Arm Description
1:30,000 bee venom (BV) acupuncture plus physiotherapy
Arm Title
NS
Arm Type
Placebo Comparator
Arm Description
Normal saline injection plus physiotherapy
Intervention Type
Procedure
Intervention Name(s)
1:10,000 bee venom (BV) acupuncture
Intervention Description
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
Intervention Name(s)
1:30,000 bee venom (BV) acupuncture
Intervention Description
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
Intervention Name(s)
normal saline injection
Intervention Description
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
Intervention Name(s)
physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
the Shoulder Pain and Disability Index (SPADI)
Time Frame
Changes from baseline in SPADI at 2, 4, 8, 12 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) for pain intensity
Time Frame
Changes from baseline in VAS at 2, 4, 8, 12 weeks
Title
passive Range of Motion (pROM)
Description
The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.
Time Frame
Changes from baseline in pROM at 2, 4, 8, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonghyeon Baek, OMD, Ph.D
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byung-Kwan Seo, OMD, Ph.D
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Study Director
Facility Information:
Facility Name
Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of

12. IPD Sharing Statement

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Bee Venom Acupuncture for the Treatment of Frozen Shoulder

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