The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome (PFSAlgorithm)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitchell Selhorst, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01767246
First received: January 9, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention
Patellofemoral Syndrome
Other: PFS Algorithm treatment
Other: Multimodal treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome: A Pilot Study

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Change in Anterior Knee Pain Scale [ Time Frame: 2 times per week for up to 6 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Global Rating of Change Scale (GROC) [ Time Frame: every visit after the initial assessment (2 times per week for up to 6 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 30
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Diagnosis of Patellofemoral Syndrome

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767246

Locations
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
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Mitchell C Selhorst, MPT Nationwide Children's Hospital
  More Information

Publications:

Responsible Party: Mitchell Selhorst, Physical Therapist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01767246     History of Changes
Other Study ID Numbers: IRB12-00635
Study First Received: January 9, 2013
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014