Clinical Trial: Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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 q
Sponsor: Nationwide Children's Hospital

Current Primary Outcome: Change in Anterior Knee Pain Scale [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Numeric Pain Rating Scale [ Time Frame: Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months ]
    The Numeric Pain rating scale asks the patient their highest pain in the last 24 hours. The Numeric Pain Rating Scale is a 0-10 scale subjectively assessing a patients perceived level of pain. With 0 on the scale = to no pain, and 10 = to the worst pain imaginable. The use of the Numerical Pain Rating Scale for assessing pain has been validated for use in PFPS patients and has been found to have a minimal detectable change of 1 points (Piva, 2009). The highest pain value is being used because of a floor effect was noted using average pain during the pilot study.
  • Global Rating of Change Scale (GROC) [ Time Frame: Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months ]
    The Global Rating of Change scale is a 15-point Likert type scale (-7 to +7). A score of 0 represents no change from initial injury, +7 represents a great deal better, and -7 represents a great deal worse. A score of +/- 3 represents a minimal clinical difference (Wang, 2011).


Original Secondary Outcome: Same as current

Information By: Nationwide Children's Hospital

Dates:
Date Received: June 1, 2015
Date Started: June 2015
Date Completion: October 2017
Last Updated: January 30, 2017
Last Verified: January 2017