Treatment for Patellofemoral Pain Syndrome Using Footwear

This study has been completed.
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: February 18, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear

Further study details as provided by 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 ] [ 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.


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 ] [ 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.


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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ryan Lewinson, Ryan T. Lewinson, University of Calgary
ClinicalTrials.gov Identifier: NCT01332110     History of Changes
Other Study ID Numbers: 23731
Study First Received: April 7, 2011
Last Updated: February 18, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 22, 2014