Phase II Study of Navigator vs Standard Needle Injection for Hip
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Injection Pain as measured by VAS for both treatment groups
研究概览
简要总结
The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.
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
- Single (Participant)
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
- •Males and females, ≥18 years of age, of any race or ethnicity;
- •Capable of completing self-administered questionnaires;
- •Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months;
- •Candidate for a hip injection;
- •Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee.
- •Subjects are able to understand and speak English
排除标准
- •History of intra-articular injection within the last 3 months prior to the injection procedure;
- •Complex regional pain syndrome;
- •History of prior hip surgery;
- •History of substance abuse;
- •Known history of hypersensitivity to local anesthetics of the amide type;
- •Contraindicated for Celestone (betamethasone sodium phosphate);
- •Contraindicated for Lidocaine Hydrochloride;
- •Is a prisoner or ward of the state;
- •Are unable to meet the treatment and follow up protocol requirements.
研究组 & 干预措施
Standard Manual Needle Injection
2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon
干预措施: Celestone (Drug)
Standard Manual Needle Injection
2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon
干预措施: Lidocaine (Drug)
Navigator Injection
2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon
干预措施: Celestone (Drug)
Navigator Injection
2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon
干预措施: Lidocaine (Drug)
结局指标
主要结局
Injection Pain as measured by VAS for both treatment groups
时间窗: From 1 week to 12 weeks post-injection
次要结局
- Global Patient Satisfaction(From 1 week to 12 weeks post-injection)
- Drug Preparation Time(From 1 week to 12 weeks post-injection)
- Hip Pain and Function(From 1 week to 12 weeks post-injection)