Persons With Mild to Moderate Knee Osteoarthritis Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 35 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Kochan Institute for Healing Arts Research | Encino | California |
| United States | Rheumatology Therapeutics Medical Center | Tarzana | California |
| Lead Sponsor | Collaborator |
|---|---|
| Rheumatology Therapeutics Medical Center | Kochan Institute for Healing Arts Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Visual Analog Scale | |||
| Primary | Change in Knee Injury and Osteoarthritis Outcome Score | |||
| Primary | Change in use of analgesic meds after 6 weeks of treatment | |||
| Primary | Change in 50 ft. walk and 4 step up/down climb time | |||
| Secondary | Adverse event incidence | |||
| Secondary | Baseline and visit 12 laboratory assessments | |||
| Secondary | Change in tenderness and motion |