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Treatment for Patellofemoral Pain Syndrome Using Footwear

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332110
First Posted: April 8, 2011
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ryan Lewinson, University of Calgary
  Purpose
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.

Condition Intervention Phase
Patellofemoral Pain Syndrome Device: Knee abduction moment-reducing footwear Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear

Further study details as provided by Ryan Lewinson, University of Calgary:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Control footwear
Standard, off-the-shelf running shoes with no mechanical modifications.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332110


Locations
Canada, Alberta
Human Performance Laboratory
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ryan Lewinson, Ryan T. Lewinson, University of Calgary
ClinicalTrials.gov Identifier: NCT01332110     History of Changes
Other Study ID Numbers: 23731
First Submitted: April 7, 2011
First Posted: April 8, 2011
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Ryan Lewinson, University of Calgary:
Footwear
Motion Analysis
Running Injury

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases