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临床试验/NCT02461095
NCT02461095已完成不适用

Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial

Nationwide Children's Hospital8 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
8
主要终点
Change in Anterior Knee Pain Scale

研究概览

简要总结

Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been identified as an important factor in patients with PFPS. The authors hypothesize that an ordered approach addressing each of these impairments sequentially will result in greater improvement in PFPS symptoms. The results of the investigators pilot study assessing the feasibility of using a sequential approach showed a full randomized controlled trial is warranted, the authors now plan to proceed with a full trial. The objective of this study is to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain Syndrome.

Methods: Patients will be randomized to a sequential treatment approach using a PFPS treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy care. Due to the constant evaluation necessary no blinding will be performed. Patients will attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month follow-up and 6 month follow-up.

详细描述

Patellofemoral pain syndrome (PFPS) accounts for 25 to 40% of knee pain in young and active individuals. PFPS is described as anterior knee pain around the patella which is aggravated by activity, particularly activities that increase patellofemoral forces such as squatting, ascending or descending stairs, running, and jumping. It is common in adolescents and physically active adults. Females are more likely to experience PFPS than males. PFPS is a multi-factorial condition with no clear etiology and is considered a syndrome and not a diagnosis. Dye has described PFPS as one of the most difficult orthopedic conditions to manage.

Multiple theories exist regarding a cause for PFPS pain. A primary theory for the cause of PFPS is abnormal patellar tracking which results in excessive patellofemoral joint compressive forces. Many factors contributing to abnormal patellar tracking have been suggested including; hip and quadriceps weakness, delayed or diminished activation of vastus medialis obliquus, increased Q-angle, altered lower extremity mechanics and decreased lower extremity flexibility. Due to the number of suggested contributory factors to PFPS pain, a vast amount of interventions exist and are frequently used by clinicians. Although, physical therapy interventions have been shown to be effective over sham interventions, many individuals will have recurrent or chronic pain. Ninety-six percent of patients report having problems four years following their diagnosis of PFPS. A possible reason for the continued pain is that PFPS is a multi-factorial condition and the treatments may not address all of the contributing factors in each individual.

If all of the contributing factors for the patient's PFPS are identified, addressing all of these factors at once may not be the best approach. Performing hip strengthening prior to quadriceps strengthening results in decreased levels of pain with exercise. Individuals with reduced flexibility are more likely to have impaired lower extremity mechanics. Performing traditional lower extremity strengthening exercises when there is impaired lower extremity mechanics results in increased patellofemoral joint contact forces.

In an attempt to better treat individuals with PFPS, classification systems to subgroup patients with PFPS have been proposed, but their effectiveness has not been evaluated. An important clinical question with classification systems is what to do when a patient does not nicely fit into one subgroup. If a patient does not meet or meets the criteria for multiple subgroups, how is the patient treated? No evidence exists on the relative frequency with which patients with PFPS fall into each of these proposed subgroups and whether these subgroups are mutually exclusive.

The clinical classification systems reported in literature only address physical impairments. Psychosocial factors have also been identified as important when treating patients with PFPS. In a study by Piva et al. fear avoidance beliefs were the strongest predictor of outcomes for function and pain. Mental health status on the Medical Outcomes Short Form-36 is correlated with severity of patellofemoral symptoms in athletes. The results of these studies highlight the necessity of addressing psychosocial factors when treating PFPS.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical Diagnosis of Patellofemoral Pain 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
  • Inability to follow directions

研究组 & 干预措施

Impairment based approach

Active Comparator

The intervention will address the patients impairments found during evaluation. Treatment will based on the Physical therapist evaluation and will be individualized to each patient.

干预措施: Impairment based approach (Other)

PFPS algorithm

Experimental

The Patellofemoral Syndrome algorithm is designed to determine what deficits a patient may have and addressing these sequentially. This subgrouping first assesses a patient fear avoidance beliefs, flexibility, body mechanics, and then strength and functional ability. The reason for sequential treatment is that there is evidence that without adequate flexibility a patient will be unable to perform exercises with proper body mechanics, and without proper mechanics strengthening and functional activity can cause increased stress on the patellofemoral joint. Progression through each specific subgroup is based on objective goals. Once the patient has met these goals they are progressed to the next treatment subgroup until discharge.

干预措施: PFPS Algorithm approach (Other)

结局指标

主要结局

Change in Anterior Knee Pain Scale

时间窗: Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months

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

  • Change in Numeric Pain Rating Scale(Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months)
  • Global Rating of Change Scale (GROC)(Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mitchell Selhorst

Physical Therapist/Research Coordinator

Nationwide Children's Hospital

研究点 (8)

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