Treatment for Patellofemoral Pain Syndrome Using Footwear

NCT ID: NCT01332110

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-08-31

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.

Conditions

Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Knee abduction moment-reducing footwear

Intervention Type: 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.

Control footwear

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

Group Type: PLACEBO_COMPARATOR

Knee abduction moment-reducing footwear

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Ryan Lewinson

Ryan T. Lewinson

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darren J. Stefanyshyn, Ph.D. P.Eng.

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Ryan T. Lewinson, B.Sc.

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Jay T. Worobets, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

J. Preston Wiley, M.D., M.P.E.

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Human Performance Laboratory

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26230399 (View on PubMed)

Other Identifiers

23731

Identifier Type: -

Identifier Source: org_study_id