NCT01332110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

April 7, 2011

Last Update Submit

February 18, 2014

Conditions

Patellofemoral Pain Syndrome

Keywords

FootwearMotion AnalysisRunning Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Knee abduction moment-reducing footwear

EXPERIMENTAL

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

Control footwear

PLACEBO COMPARATOR

Standard, off-the-shelf running shoes with no mechanical modifications.

Device: Knee abduction moment-reducing footwear

Interventions

Knee abduction moment-reducing footwearDEVICE

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.

Control footwearKnee abduction moment-reducing footwear

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26230399DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ryan T. Lewinson

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 8, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2012

Study Completion

August 1, 2012

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

CA(1)