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Completed

NCT Number: NCT02352909

A Controlled Trial on Recreational Runners With Patellofemoral Pain

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.

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Key information

Conditions

Patellofemoral Pain (PFPS) Joint Diseases Musculoskeletal Diseases Patellofemoral Pain Syndrome

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, G1M 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

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.

exercise program

Other

A home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks.

Gait retraining

Other

Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2015
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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