Intra-articularInjection of Botulinum Toxin Type

Status unconfirmed · Phase 2

Conditions studied: Arthritis, Pain

In brief

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.

Key facts

Study ID

NCT00211679

Run by

Minneapolis Veterans Affairs Medical Center

People needed

40

Starts

2004-06-01

Expected to finish

2007-06-01

Last updated by the study team

2005-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Minneapolis VAMC — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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