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Treatment for Patellofemoral Pain Syndrome Using Footwear

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ryan Lewinson, University of Calgary
ClinicalTrials.gov Identifier:
NCT01332110
First received: April 7, 2011
Last updated: October 26, 2011
Last verified: October 2011
History of Changes

April 7, 2011
October 26, 2011
June 2011
December 2011   (final data collection date for primary outcome measure)
Knee joint internal abduction moments of force during running at 4m/s [ Time Frame: First day of joining the study ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01332110 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Treatment for Patellofemoral Pain Syndrome Using Footwear
Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing 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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Patellofemoral Pain Syndrome
Device: 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.
  • Experimental: 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.
    Intervention: Device: Knee abduction moment-reducing footwear
  • Placebo Comparator: Control footwear
    Standard, off-the-shelf running shoes with no mechanical modifications.
    Intervention: Device: Knee abduction moment-reducing footwear
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
February 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01332110
23731
Not Provided
Ryan Lewinson, University of Calgary
University of Calgary
Canadian Institutes of Health Research (CIHR)
Principal Investigator: 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
University of Calgary
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP