A Randomized, Pragmatic, Effectiveness Trial Evaluating Intra-articular Hyaluronan for the Symptomatic Treatment of Chronic Patellofemoral Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) Score
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.
详细描述
Objective: To determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.
Study Design: Two-arm, single-center, parallel, pragmatic, randomized, non-blinded, effectiveness trial
Indication for Use: For treatment of adult patients with Patellofemoral Pain Syndrome (PFPS) who have failed to respond to conservative treatment and simple analgesics (e.g. acetaminophen).
Setting: University Teaching Hospital, Faculty Practice
Subjects: Male and female patients aged 18-40 diagnosed with symptomatic patellofemoral pain syndrome (PFPS) that meet all inclusion and exclusion criteria. Approximately 68 subjects will be enrolled based on a power analysis of sample size estimation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults from the ages of 18-40, male or female
- •Diagnosis of unilateral OR bilateral patellofemoral pain syndrome
- •Duration of diagnosis no less than 2 months and no greater than 3 years in the study knee
- •Unresponsive to standard treatment of at least 6 weeks duration, consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy
- •Insidious onset of symptoms unrelated to a traumatic incident
- •Pain described as "behind", "underneath", or "around" the patella reported during at least two of the following activities:
- •Going up or down stairs
- •Squatting
- •Hopping or jumping
- •Prolonged sitting
- •A baseline activity related VAS pain score between 50 and 90
排除标准
- •Any co-morbidity that would influence the safety of intra-articular injections or impede safety and efficacy measurements in the study knee, such as:
- •Coagulopathies or the use of anticoagulant medications
- •History of allergy to any of the treatment interventions planned
- •Acute inflammation and/or palpable effusion in the study knee
- •Current or history of musculoskeletal infection in the study knee
- •Severe malalignment, deformity or chronic subluxation of study knee
- •History of prior patellar dislocation of the study knee
- •Ipsilateral joint/limb conditions (e.g. hip, thigh, lower leg, ankle, foot)
- •Any condition other than PFPS in the contralateral knee present at the time of enrollment or developing during the course of enrollment
- •Any radiographic signs of the following:
- •Osteoarthritis in any of the study knee compartments
- •Osteochondritis dissecans (OCD) lesions
- •Physeal injuries
- •Bone tumors
- •Vulnerable subjects and pregnant women
- •Participation in any other musculoskeletal studies
结局指标
主要结局
Change in Visual Analog Scale (VAS) Score
时间窗: At baseline and 3 month follow-up
A 100mm visual analog scale (VAS) for activity related pain assessment will serve as the primary outcome measure. The 2-sample t-test comparing the two treatment groups' mean change from baseline issued. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The 2 sample t-test approximates the test of the null hypothesis that there is a difference in mean change from baseline in the VAS for activity-related pain between the HA group and control group. Higher scores indicate higher level of pain.
次要结局
- PFPS Severity Scale (PSS) Score(3 month follow-up)