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Completed

NCT Number: NCT01332110

Treatment for Patellofemoral Pain Syndrome Using 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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Human Performance Laboratory

Calgary, Alberta, T2N 1N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee abduction moment-reducing footwear

Device

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.

Primary outcomes

  1. Knee joint internal abduction moments of force during running at 4m/s

    Time frame: 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 outcomes

  1. Change in subjective levels of perceived knee pain over six weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2011
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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