Status:
UNKNOWN
Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis
Lead Sponsor:
Rheumatology Therapeutics Medical Center
Collaborating Sponsors:
Kochan Institute for Healing Arts Research
Conditions:
Persons With Mild to Moderate Knee Osteoarthritis
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and di...
Eligibility Criteria
Inclusion
- Meet clinical criteria for Osteoarthritis in one knee
- Morning stiffness less than 30 minutes duration
- VAS pain level of 4 to 8 on a 0 to 10 scale when walking
- Older than 35 years of age
- On a stable dose of medication or none at all due to intolerance
- Ability to tolerate Acetaminophen as their only pain medication for the entire study
- Ability to read, understand, and give informed consent and sign the informed consent form
Exclusion
- Allergy to bee venom or histamine
- Allergy to Lidocaine
- Any type of inflammatory arthritis such as RA, SLE, Psoriatic
- Fibromyalgia or any pain problem that requires the use of pain medication or anti-inflammatory
- Depression or any condition that interferes with memory or critical analysis
- History of prolotherapy, bee venom therapy, or injection of hyaluronic acid or cortisone within the last 3 months
- Osteoarthritis of the hip, ankle, or any condition that interferes with walking 50 ft. or up and down stairs
- Elevated CRP, SED rate
- Recent injury to the knee which is causing pain or functional problems
- Any previous invasive procedure on the study knee
- Inability to understand the informed consent form or refusal to sign it
- Cardiac disease interfering with ability to get epinephrine
- VAS pain level greater than 8 on a 0 to 10 scale when walking
- Inability to stop anti-inflammatory medication for the entire study and use only Acetaminophen
- Taking beta blockers
- Taking chronic anti-histamines
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00253942
Start Date
November 1 2005
Last Update
November 15 2005
Active Locations (2)
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1
Kochan Institute for Healing Arts Research
Encino, California, United States, 91316
2
Rheumatology Therapeutics Medical Center
Tarzana, California, United States, 91356