Clinical Trials Logo
  1. Home
  2. Frozen Shoulder
  3. NCT01526031
  4. Details
NCT01526031 Clinical Trial

Bee Venom Acupuncture for the Treatment of Frozen Shoulder

Frozen Shoulder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01526031
Other study ID # KHNMC-OH-IRB 2009-013
Secondary ID
Status Completed
Phase Phase 2
First received February 1, 2012
Last updated February 1, 2012
Start date January 2010
Est. completion date July 2010

Study information
Verified date February 2012
Source Kyunghee University Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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)
• 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)
• 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)
• 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

Locations
Country Name City State
Korea, Republic of Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong Seoul

Sponsors (2)
Lead Sponsor Collaborator
Kyunghee University Medical Center Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the Shoulder Pain and Disability Index (SPADI) Changes from baseline in SPADI at 2, 4, 8, 12 weeks No
Secondary Visual Analogue Scale (VAS) for pain intensity Changes from baseline in VAS at 2, 4, 8, 12 weeks No
Secondary passive Range of Motion (pROM) The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked. Changes from baseline in pROM at 2, 4, 8, 12 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT06181461 - Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis N/A
Recruiting NCT03676829 - Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis Phase 1/Phase 2
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT04747938 - Frozen Shoulder Treated by Energy Accumulator N/A
Recruiting NCT05979974 - High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder N/A
Completed NCT02169206 - Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position N/A
Enrolling by invitation NCT03861923 - Dry Needling for Shoulder Adhesive Capsulitis N/A
Completed NCT06391567 - Balance in People With Frozen Shoulder
Not yet recruiting NCT05956171 - The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder N/A
Completed NCT03320200 - A Central Nervous System Focused Treatment Approach for Frozen Shoulder N/A
Recruiting NCT04738253 - Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients
Not yet recruiting NCT06129006 - Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder N/A
Completed NCT02944526 - The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial Phase 4
Recruiting NCT02283996 - Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment Phase 4
Completed NCT02006719 - Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT01483963 - AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT04369144 - Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder N/A
Completed NCT03951896 - Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder Early Phase 1
Completed NCT05993000 - Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial N/A
Completed NCT05372497 - Central Nervous System Focused Therapy in Frozen Shoulder N/A