The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- VAS Pain
研究概览
简要总结
The purpose of this study is to determine whether outcomes for patients receiving intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis are influenced by observation of the preparatory steps to the procedure. The viewing of the steps involved in the administration of PRP may increase the effectiveness of the treatment in comparison to patients who have not observed the preparatory steps.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women ages 50-80 years
- •Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria
- •Provision of informed consent
排除标准
- •Patients with inflammatory osteoarthritis
- •Open wounds or sores over the knee joint
- •Patients that will likely have problems, in the judgement of the investigators, with maintaining follow-up
研究组 & 干预措施
Viewing of preparation
The patient will be in the room for the preparation of the PRP and will receive a description of the centrifuge process from the physician administering the injection.
干预措施: Platelet-rich plasma (PRP) (Biological)
Blinded to preparation
The patient will leave the room after their blood is drawn and will not view the preparation of the PRP, and will also not receive a description of the centrifuge process.
干预措施: Platelet-rich plasma (PRP) (Biological)
Viewing of preparation
The patient will be in the room for the preparation of the PRP and will receive a description of the centrifuge process from the physician administering the injection.
干预措施: Viewing of preparation (Behavioral)
结局指标
主要结局
VAS Pain
时间窗: 12 weeks
Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(12 weeks)
- Short Form 12 (SF-12) Functional outcome assessment(12 weeks)
- Range of motion(12 weeks)