Recruiting
Phase 3

Bee Venom

Sponsor:

Rheumatology Therapeutics Medical Center

Code:

NCT00253942

Conditions

Persons With Mild to Moderate Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Interventions

Injecting bee venom as a treatment for OA

Study Details

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 discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.

Conditions

Persons With Mild to Moderate Knee Osteoarthritis

Study ID

NCT00253942

Start date

Nov, 2005

Status verified date

Oct, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

40 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Injecting bee venom as a treatment for OA

Primary outcome measure

  • Change in Visual Analog Scale [ Time Frame: undefined ]
  • Change in Knee Injury and Osteoarthritis Outcome Score [ Time Frame: undefined ]
  • Change in use of analgesic meds after 6 weeks of treatment [ Time Frame: undefined ]
  • Change in 50 ft. walk and 4 step up/down climb time [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Kochan Institute for Healing Arts Research

Recruiting

Encino, California, United States, 91316

Contacts

Ray Seipel, MA

818-995-9331ray@healingartsresearch.org

Principal Investigator:

Andrew Kochan, MD

Rheumatology Therapeutics Medical Center

Recruiting

Tarzana, California, United States, 91356

Contacts

Phil Sheng, BS

818-996-4077Phil.Sheng@Gmail.com

Principal Investigator:

Boris Ratiner, MD

More Information

Sponsor

Rheumatology Therapeutics Medical Center

Last update posted

Nov 15, 2005

Last verified

Oct, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rheumatology Therapeutics Medical Center on 2005-11-15.