Treatment for Patellofemoral Pain Syndrome Using Footwear

Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear

Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be associated with higher than normal knee joint loading. Footwear has been developed that may decrease these knee loads in healthy subjects, but their effects on patients with PFPS are unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We hypothesize that patients who receive the footwear intervention will show a decrease in knee joint loading, and consequently will show improvements in subjective levels of perceived knee pain over a period of six weeks compared to a control condition.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Device: Knee abduction moment-reducing footwear

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Human Performance Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female between 18 and 45 years of age.
• Have been diagnosed with patellofemoral pain syndrome (PFPS) by a physician.
• Have nontraumatic unilateral and/or bilateral peripatellar or retropatellar knee pain.
• Patellofemoral knee pain with and/or after activity.
• Inactivity patellofemoral pain and/or stiffness, especially with sitting with knees held in flexed posture.
• Peripatellar tenderness ± mild inferior patellar pole tenderness.
• Run at least 15km per week.
• Are heel-toe runners (as opposed to forefoot strikers).

Exclusion Criteria:

• Are currently, or have previously, participated in any other forms of treatment for their knee pain.
• Significant articular or periarticular effusion or bursitis.
• Significant joint line tenderness.
• Intra-articular ligamentous instability.
• Patellar apprehension.
• Have undergone any form of knee surgery or arthroscopy.
• Have any other neuromuscular, musculoskeletal or cardiovascular conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Knee abduction moment-reducing footwear; Footwear that is known to decrease knee abduction moments of force in healthy subjects. May include orthotics, or footwear that allows relative movement between the heel section of the outsole and rest of the shoe.	Device: Knee abduction moment-reducing footwear; Patients in each study group will be asked to run using their assigned footwear at least 3 times per week (minimum 15 km per week) for six weeks. Each patient will document their perceived knee pain each week throughout the six week intervention.
PLACEBO_COMPARATOR: Control footwear; Standard, off-the-shelf running shoes with no mechanical modifications.	Device: Knee abduction moment-reducing footwear; Patients in each study group will be asked to run using their assigned footwear at least 3 times per week (minimum 15 km per week) for six weeks. Each patient will document their perceived knee pain each week throughout the six week intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee joint internal abduction moments of force during running at 4m/s	Motion analysis trials will be conducted on each subject with both the control and intervention footwear. Inverse dynamics calculations will reveal the internal joint loading for each subject. Knee joint moments will be compared within subjects for each footwear condition.	First day of joining the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective levels of perceived knee pain over six weeks	Pain levels will be recorded by 100mm visual analog scale during weeks 1, 2, 3, 4, 5 and 6 of the study to monitor the efficacy of the intervention. Final change in pain will be compared between groups.	Upon initial recruitment to the study, and once per week for six weeks thereafter

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Darren J. Stefanyshyn, Ph.D. P.Eng., University of Calgary; Principal Investigator: Ryan T. Lewinson, B.Sc., University of Calgary; Principal Investigator: Jay T. Worobets, Ph.D., University of Calgary; Principal Investigator: J. Preston Wiley, M.D., M.P.E., University of Calgary

Publications and helpful links

General Publications

• Lewinson RT, Wiley JP, Humble RN, Worobets JT, Stefanyshyn DJ. Altering Knee Abduction Angular Impulse Using Wedged Insoles for Treatment of Patellofemoral Pain in Runners: A Six-Week Randomized Controlled Trial. PLoS One. 2015 Jul 31;10(7):e0134461. doi: 10.1371/journal.pone.0134461. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (ESTIMATE): April 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 18, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Footwear; Motion Analysis; Running Injury
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 23731