Intra-articularInjection of Botulinum Toxin Type
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in Pain Score []
- Change in Joint Function []
- Patient Global Assessment []
Secondary Outcome Measures
- Pain Relief []
- Change in Health Status Quality of Life-SF36 []
- Change in Disease specific Health Related QOL-WOMAC []
- Function improvement by Timed Stands Test and Range of Motion []
- Physican Assessment of Pain and Global Assessment of Improvement []
- Safety Measure, []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects, 18 years of age or older.
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Written informed consent and written authorization for use or release of health and research study information have been obtained.
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Subject has chronic Knee pain for more than 1 year.
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Subject has pain >4.5 on numerical rating scale of 0 to 10.
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Ability to follow study instructions and likely to complete all required visits.
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Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable)
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Patients previously treated with intra-articular corticosteroid or viscosupplementation injections.
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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.
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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.
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Must be ambulatory and able to perform sit to stand.
Exclusion Criteria:
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Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
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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.
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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.
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Known allergy or sensitivity to any of the components in the study medication.
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Evidence of recent alcohol or drug abuse.
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Infection at injection site or systemic infection (postpone study entry until one week following recovery.
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Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months.
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Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
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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.
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Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit
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Patients on coumadin or heparin because of increased risk of bleeding in the joint
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Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Minneapolis VAMC | Minneapolis | Minnesota | United States | 55417 |
Sponsors and Collaborators
- Minneapolis Veterans Affairs Medical Center
- Allergan
- Center for Veterans Research and Education
Investigators
- Principal Investigator: Maren L Mahowad, MD, Minneapolis VAMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Protocol Number 03393B