intra-articularinjection of botulinum toxin type

Conditions: Arthritis; Pain

Summary: the purpose of this study is to determine whether intra-articular injection of botulinum toxin is effective in the treatment of chronic knee paindue to arthritis.

chronic knee pain unresponsive to oral medications and intra-articular corticosteroids and viscosupplements is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. we hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. this is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter. comparisons: intra-articular injection of bootulinum toxin type a will be compared to intra-articular injection of lidocaine the saline.

Eligibility criteria:
inclusion criteria: * male or female subjects, 18 years of age or older. * written informed consent and written authorization for use or release of health and research study information have been obtained. * subject has chronic knee pain for more than 1 year. * subject has pain \>4.5 on numerical rating scale of 0 to 10. * ability to follow study instructions and likely to complete all required visits. * negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable) * patients previously treated with intra-articular corticosteroid or viscosupplementation injections. * patients with rheumatoid arthritis must have failed therapy with standard dmards (disease modifying anti-rheumatic drugs) and anti-tnf agents unless they have a contraindication to tnf blockers. * patients who were considered not to be candidates for knee joint replacement because of young age, abnormalities in periarticular tissues or because of co-morbid conditions. * must be ambulatory and able to perform sit to stand. exclusion criteria: * use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function. * any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, eaton-lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy. * females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study. * known allergy or sensitivity to any of the components in the study medication. * evidence of recent alcohol or drug abuse. * infection at injection site or systemic infection (postpone study entry until one week following recovery. * known, uncontrolled serious systemic disease and/or life expectancy less than 12 months. * concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment. * any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. * patients whose pain is rated as less than 4.5 on a 10 point numerical pain rating scale at the screening visit * patients on coumadin or heparin because of increased risk of bleeding in the joint * serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.

Keywords: joint pain knee pain arthritis intra-articular botulinum toxin type a