The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change in Anterior Knee Pain Scale
研究概览
简要总结
Patients who are diagnosed with Patellofemoral Pain Syndrome (PFS) and present to our clinic will be offered the opportunity to participate in the study. If they consent to be in this study they will randomized into 2 treatment groups. The experimental treatment group will be treated according to the novel PFS treatment algorithm. The control group will receive treatment that would be considered standard physical therapy care. To apply standard physical therapy care in a standardized manner the investigators are using a multimodal treatment approach that has been previously shown by Lowry to be beneficial in the treatment of PFS. Both groups of subjects will be seen 2 times per week for a maximum of 12 visits. Patients can be discharged early if they no longer report pain or impaired function on the Anterior Knee Pain scale.
The purpose of this study is to see if patients with patellofemoral pain syndrome treated with the experimental Patellofemoral treatment algorithm experience significant improvements in function, pain and the number of treatment sessions compared with a previously researched multimodal approach to the treatment of patellofemoral pain.
The secondary objective of this study is to examine results to determine if a full randomized controlled clinical trial of the PFS algorithm is justified.
The investigators hypothesize that utilization of the Patellofemoral syndrome treatment algorithm with evaluation and treatment of patients diagnosed with PFS will lead to significant improvements in function, pain and the number of treatment sessions when compared to previously researched treatment of PFS.
详细描述
Patients referred to for physical therapy with the diagnosis of Patellofemoral Pain Syndrome will be offered the opportunity to participate in the study. After explaining the study and answering any patient or parent questions, informed consent will be obtained for those individuals wishing to participate. The participants will be screened to see if they meet the inclusion criteria, and will be randomly assigned to either evaluation and treatment using the novel PFS treatment algorithm(experimental group) or evaluation and treatment using the multimodal approach to PFS. The evaluating therapist will take all measurements and perform treatments with the patients, and cannot be blinded to group allocation. The patient will not be made aware of if they are in the experimental or control group, but cannot be blinded to the treatment that they receive.
Multimodal approach to PFS: Patients randomized to the control treatment group will be treated in a manner consistent with a treatment approach previously described in literature that has been found effective in treating Patellofemoral Syndrome.
Multimodal PFS Evaluation
Postural Exam
- Lower Extremity (LE) Alignment
- Pelvic Rotation
- Navicular Drop
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Patellofemoral Syndrome
排除标准
- •Tenderness to palpation of patellar tendon, inferior pole of patella, or tibial tubercle as primary complaint
- •Patient is pregnant or nursing
- •Patient has other current lower extremity injuries
- •History of patellar subluxation or dislocations
- •History of knee surgery
结局指标
主要结局
Change in Anterior Knee Pain Scale
时间窗: 2 times per week for up to 6 weeks
Assessment of change of the Anterior Knee Pain Scale (AKPS). The AKPS is a self-reported 13 item questionnaire with discrete categories related to various levels of current knee function. Categories within each item are weighted, and responses are summed to provide an overall score of 0-100, with 100 representing no disability. The Anterior Knee Pain Scale is found to be valid and reliable in patients from 12-50 years of age presenting with anterior knee pain with a test-retest reliability of .95 (Watson, 2005). A change of 10 points represent the minimal clinical difference (Crossley, 2004).
次要结局
- Number of treatment session(at subject's discharge from study (expected average to be 6 weeks))
- Global Rating of Change Scale (GROC)(every visit after the initial assessment (2 times per week for up to 6 weeks))
- Numerical Pain Rating Scale (NPRS)(at every visit (2 times per week for up to 6 weeks))
研究者
Mitchell Selhorst
Physical Therapist
Nationwide Children's Hospital