Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Rheumatology Therapeutics Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kochan Institute for Healing Arts Research
Information provided by:
Rheumatology Therapeutics Medical Center
ClinicalTrials.gov Identifier:
NCT00253942
First received: November 10, 2005
Last updated: November 14, 2005
Last verified: October 2005
  Purpose

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.


Condition Intervention Phase
Persons With Mild to Moderate Knee Osteoarthritis
Procedure: Injecting bee venom as a treatment for OA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Histamine-Controlled, Phase 3 Study to Determine the Safety and Efficacy of Bee Venom in the Treatment of Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Rheumatology Therapeutics Medical Center:

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

Secondary Outcome Measures:
  • Adverse event incidence
  • Baseline and visit 12 laboratory assessments
  • Change in tenderness and motion

Estimated Enrollment: 40
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253942

Locations
United States, California
Kochan Institute for Healing Arts Research Recruiting
Encino, California, United States, 91316
Contact: Ray Seipel, MA    818-995-9331    ray@healingartsresearch.org   
Principal Investigator: Andrew Kochan, MD         
Rheumatology Therapeutics Medical Center Recruiting
Tarzana, California, United States, 91356
Contact: Phil Sheng, BS    818-996-4077 ext 217    Phil.Sheng@Gmail.com   
Principal Investigator: Boris Ratiner, MD         
Sponsors and Collaborators
Rheumatology Therapeutics Medical Center
Kochan Institute for Healing Arts Research
Investigators
Principal Investigator: Boris Ratiner, MD Medical Director of Rheumatology Therapeutics Medical Center
Principal Investigator: Andrew Kochan, MD Medical Director of Kochan Institute for Healing Arts Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00253942     History of Changes
Other Study ID Numbers: OABVTKNEE-001
Study First Received: November 10, 2005
Last Updated: November 14, 2005
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014