Treatment for Patellofemoral Pain Syndrome Using Footwear

Phase 1

Completed

• Conditions: Patellofemoral Pain Syndrome
• Interventions: Device: Knee abduction moment-reducing footwear

• Registration Number: NCT01332110
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Study Start: 2011-06
• Primary Completion: 2012-01
• Study Completion: 2012-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knee abduction moment-reducing footwear	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.
Control footwear	Knee abduction moment-reducing footwear	Standard, off-the-shelf running shoes with no mechanical modifications.

Primary Outcome Measures

Name	Time	Method
Knee joint internal abduction moments of force during running at 4m/s	First day of joining the study	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.

Secondary Outcome Measures

Name	Time	Method
Change in subjective levels of perceived knee pain over six weeks	Upon initial recruitment to the study, and once per week for six weeks thereafter	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.

Trial Locations

Locations (1)

Human Performance Laboratory; 🇨🇦 Calgary, Alberta, Canada