A Controlled Trial on Recreational Runners With Patellofemoral Pain

September 7, 2016 updated by: Laval University

A Randomised Controlled Trial on Recreational Runners With Patellofemoral Pain: Effects of Rehabilitation Approaches Based on Specific Underlying Mechanisms

From a rehabilitation point of view, while several approaches exist to retrain runners with PFPS, it is not clear which one is most effective, or why. The goals of this randomised-controlled trial are: 1) to compare the effectiveness of three rehabilitation programs on pain and functional limitations of runners with PFPS and 2) to explain why the programs are effective or not based on laboratory analyses. After baseline evaluation, runners will be randomly assigned to one of three treatment groups, each with a specific 8-week rehabilitation program aimed at addressing the efficiency of a specific type of retraining. These groups are: 1) Control; 2) muscle recruitment; 3) reducing knee loading during running.

The investigators hypothesis is that the intervention targeting a reduction in knee loading will be significantly more effective in reducing symptoms and improving function of runners with patellofemoral pain syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis will be tested using symptoms and functional status questionnaires. In addition, mechanistic analyses will be conducted using a running assessment using an instrumented treadmill and kinematics analyses.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1M 2S8
        • Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Running mileage at least 15km
  • Symptoms since at least 3 months
  • Pain level at least 3/10 during running and 3 activities among: kneeling, squatting, stairs and resisted knee extension
  • Score lower than 85/100 on the KOS-ADLS

Exclusion Criteria:

  • History of knee surgery or patellar dislocation
  • Pain believed to originate either from meniscus or from patellar tendon
  • Pain following an acute trauma
  • Concurrent lower limb injuries
  • History of neurological, inflammatory, rheumatoid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Education will be given on how to modify running training to encourage improvement of symptoms.
Other: Education
Education on running training modifications depending on symptoms (decrease running speed, spread running volume throughout the week, run/walk intervals, avoid downhill and stairs running). Education about symptoms will also be provided.
Experimental: Muscle recruitment
Subjects will receive an additional exercise program targeting non task-specific strengthening and motor control exercises of the lower limb.
Other: Education
Education on running training modifications depending on symptoms (decrease running speed, spread running volume throughout the week, run/walk intervals, avoid downhill and stairs running). Education about symptoms will also be provided.
Other: Exercise program
A home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks.
Experimental: Reduction of knee loading
Subjects will receive additional personalized advice on how to modify running gait in order to reduce mechanical loads at the knee (gait retraining).
Other: Education
Education on running training modifications depending on symptoms (decrease running speed, spread running volume throughout the week, run/walk intervals, avoid downhill and stairs running). Education about symptoms will also be provided.
Other: Gait retraining
Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in symptoms and function using a self-reported questionnaire, the Activities of Daily Living Scale of the Knee Outcome Survey (KOS-ADLS)
Time Frame: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
A validated self-reported questionnaire (found to have the best psychometric properties in this population by a systematic review; Esculier et al., Disabil Rehabil 2013;35(26):2181-90) will be used to assess the severity of symptoms and functional limitations during the activities of daily living because of knee impairment. Changes in scores to this questionnaire will allow to compare the efficacy of rehabilitation protocols.
After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain scores using Visual analog scales (VAS)
Time Frame: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
Visual analog scales will be used to assess levels of usual pain, worst pain and pain during running. Changes in scores to these scales will allow to compare the efficacy of rehabilitation protocols. These pain scales have been validated in this population.
After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
Global rating of change (GRC)
Time Frame: After the intervention (8 weeks)
Self-reported outcome used to monitor perception of improvement or worsening of the condition following the intervention.
After the intervention (8 weeks)
Changes in the vertical loading rate of ground reaction forces during treadmill running
Time Frame: Baseline and after the intervention (8 weeks)
Vertical ground reaction forces and vertical loading rate during running on a Bertec instrumented treadmill. The average and instantaneous rise in vertical ground reaction forces will be considered between initial contact and initial peak in vertical forces. Data will be collected during running between 8-10km/h on a Bertec instrumented treadmill.
Baseline and after the intervention (8 weeks)
Changes in ankle, knee, hip and pelvis kinematics during the stance phase of running
Time Frame: Baseline and after the intervention (8 weeks)
Analysis of 3-dimensions motion of the lower limbs during running using VICON cameras. Peak angles and angular excursions will be assessed.
Baseline and after the intervention (8 weeks)
Changes in patellofemoral joint load during the stance phase of running
Time Frame: Baseline and after the intervention (8 weeks)
Using inverse dynamics, patellofemoral joint load during the stance phase of running will be estimated by combining kinematics data with force plates data.
Baseline and after the intervention (8 weeks)
Changes in lower limb muscle strength
Time Frame: Baseline and after the intervention (8 weeks)
Maximum isometric strength testing of the knee extensors and hip abductors, extensors and external rotators will be assessed using a handheld dynamometer with standard procedures.
Baseline and after the intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-15-1 (OPPQ-REPAR)
  • PFC-2014 (Other Grant/Funding Number: Physiotherapy Foundation of Canada, Sports Division)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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