The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome (PFSAlgorithm)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01767246|
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : July 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Syndrome||Other: PFS Algorithm treatment Other: Multimodal treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome: A Pilot Study|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: PFS algorithm treatment
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.
Other: PFS Algorithm treatment
Physical Therapy treatment for Patellofemoral Syndrome based upon a treatment algorithm. that addresses patients: fear avoidance beliefs, flexibility, body mechanics, and strength. The exercises and treatments are individualized to each patients with the goal of have low fear avoidance beliefs, flexibility, body mechanics, and strength.
Active Comparator: Multimodal Treatment
Patients randomized to the this treatment group will be treated in a manner consistent with a Multimodal treatment approach previously described in literature that has been found effective in treating Patellofemoral Syndrome (Lowry, 2008). Treatment consists of strengthening, flexibility and manual treatments aim to improve patients knee pain.
Other: Multimodal treatment
Physical Therapy treatment for Patellofemoral Syndrome based upon the Multimodal treatment (Lowry, 2008).
- Change in Anterior Knee Pain Scale [ Time Frame: 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).
- Global Rating of Change Scale (GROC) [ Time Frame: every visit after the initial assessment (2 times per week for up to 6 weeks) ]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).
- Number of treatment session [ Time Frame: at subject's discharge from study (expected average to be 6 weeks) ]The number of treatment sessions needed for the patient to achieve full function needed
- Numerical Pain Rating Scale (NPRS) [ Time Frame: at every visit (2 times per week for up to 6 weeks) ]The NPRS 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 PFS patients and has been found to have a minimal detectable change of 1 points (Piva, 2009).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767246
|United States, Ohio|
|Nationwide Children's Hospital Sports and Orthopedic PT East Broad St location|
|Columbus, Ohio, United States, 43213|
|Nationwide Children's Hospital Sports and Orthopedic PT Westerville location|
|Westerville, Ohio, United States, 43082|
|Principal Investigator:||Mitchell C Selhorst, MPT||Nationwide Children's Hospital|