Clinical trial NCT01332110: Treatment for Patellofemoral Pain Syndrome Using Footwear
Official title: Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Patellofemoral Pain Syndrome
Keywords: Footwear
Motion Analysis
Running Injury
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Knee joint internal abduction moments of force during running at 4m/s
timeFrame: First day of joining the study
Secondary outcomes:
measure: Change in subjective levels of perceived knee pain over six weeks
timeFrame: Upon initial recruitment to the study, and once per week for six weeks thereafter
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Human Performance Laboratory
state: Alberta
Study officials:
affiliation: University of Calgary
name: Darren J. Stefanyshyn, Ph.D. P.Eng.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Ryan T. Lewinson, B.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Jay T. Worobets, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: J. Preston Wiley, M.D., M.P.E.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.