Treatment for Patellofemoral Pain Syndrome Using Footwear

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332110
• Other study ID #: 23731
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 7, 2011
• Last updated: February 18, 2014
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Human Performance Laboratory	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee joint internal abduction moments of force during running at 4m/s	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.	First day of joining the study	No
Secondary	Change in subjective levels of perceived knee pain over six weeks	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.	Upon initial recruitment to the study, and once per week for six weeks thereafter	No