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Treatment for Patellofemoral Pain Syndrome Using Footwear

Primary Purpose

Patellofemoral Pain Syndrome

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Knee abduction moment-reducing footwear

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Footwear, Motion Analysis, Running Injury

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Human Performance Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Knee abduction moment-reducing footwear

Control footwear

Arm Description

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.

Standard, off-the-shelf running shoes with no mechanical modifications.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01332110

First Posted

April 7, 2011

Last Updated

February 18, 2014

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT01332110

Brief Title

Treatment for Patellofemoral Pain Syndrome Using Footwear

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patellofemoral Pain Syndrome

Keywords

Footwear, Motion Analysis, Running Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Knee abduction moment-reducing footwear

Arm Type

Experimental

Arm Description

Arm Title

Control footwear

Arm Type

Placebo Comparator

Arm Description

Standard, off-the-shelf running shoes with no mechanical modifications.

Intervention Type

Device

Intervention Name(s)

Knee abduction moment-reducing footwear

Intervention Description

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.

Primary Outcome Measure Information:

Title

Knee joint internal abduction moments of force during running at 4m/s

Description

Time Frame

First day of joining the study

Secondary Outcome Measure Information:

Title

Change in subjective levels of perceived knee pain over six weeks

Description

Time Frame

Upon initial recruitment to the study, and once per week for six weeks thereafter

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darren J. Stefanyshyn, Ph.D. P.Eng.

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ryan T. Lewinson, B.Sc.

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jay T. Worobets, Ph.D.

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

J. Preston Wiley, M.D., M.P.E.

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Human Performance Laboratory

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 1N4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

26230399

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.

Results Reference

derived

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Treatment for Patellofemoral Pain Syndrome Using Footwear

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