Treatment for Patellofemoral Pain Syndrome Using Footwear

Study Overview
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Brief Summary
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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.

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

Conditions
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Patellofemoral Pain Syndrome

Intervention / Treatment
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* Device: Knee abduction moment-reducing footwear


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee abduction moment-reducing footwear<br>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<br>* 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.<br>|
| Placebo Comparator: Control footwear<br>Standard, off-the-shelf running shoes with no mechanical modifications. | Device: Knee abduction moment-reducing footwear<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Footwear, Motion Analysis, Running Injury