NCT00211679Unknown2 期
Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study
Minneapolis Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Pain Score
Change in Joint Function
Patient Global Assessment
次要结局
- 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,
研究者
研究点 (2)
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