An interventional study of Education and Exercise program in Patellofemoral Pain (PFPS), sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-09-08.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
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.
299 studies on the registry are indexed under Patellofemoral Pain Syndrome; 74 are open to participants now.
This study's enrollment of 69 is above the median of 46 across 246 interventional studies indexed under Patellofemoral Pain Syndrome.
Browse Patellofemoral Pain Syndrome studies →Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Education will be given on how to modify running training to encourage improvement of symptoms.
Other: Education
Subjects will receive an additional exercise program targeting non task-specific strengthening and motor control exercises of the lower limb.
Other: Education · Other: Exercise program
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 · Other: Gait retraining
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.
A home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks.
Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).
Changes in symptoms and function using a self-reported questionnaire, the Activities of Daily Living Scale of the Knee Outcome Survey (KOS-ADLS)
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.
Time frame: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
Changes in pain scores using Visual analog scales (VAS)
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.
Time frame: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
Global rating of change (GRC)
Self-reported outcome used to monitor perception of improvement or worsening of the condition following the intervention.
Time frame: After the intervention (8 weeks)
Changes in the vertical loading rate of ground reaction forces during treadmill running
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.
Time frame: Baseline and after the intervention (8 weeks)
Changes in ankle, knee, hip and pelvis kinematics during the stance phase of running
Analysis of 3-dimensions motion of the lower limbs during running using VICON cameras. Peak angles and angular excursions will be assessed.
Time frame: Baseline and after the intervention (8 weeks)
Changes in patellofemoral joint load during the stance phase of running
Using inverse dynamics, patellofemoral joint load during the stance phase of running will be estimated by combining kinematics data with force plates data.
Time frame: Baseline and after the intervention (8 weeks)
Changes in lower limb muscle strength
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.
Time frame: Baseline and after the intervention (8 weeks)
The record gives a start of Jul 2014, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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