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A Controlled Trial on Recreational Runners With Patellofemoral Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT02352909
First received: December 3, 2014
Last updated: September 7, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Patellofemoral Pain (PFPS) Other: Education Other: Exercise program Other: Gait retraining

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial on Recreational Runners With Patellofemoral Pain: Effects of Rehabilitation Approaches Based on Specific Underlying Mechanisms

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 69
Study Start Date: July 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02352909

Locations
Canada, Quebec
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Quebec City, Quebec, Canada, G1M 2S8
Sponsors and Collaborators
Laval University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02352909     History of Changes
Other Study ID Numbers: 2014-15-1 (OPPQ-REPAR)
PFC-2014 ( Other Grant/Funding Number: Physiotherapy Foundation of Canada, Sports Division )
Study First Received: December 3, 2014
Last Updated: September 7, 2016

ClinicalTrials.gov processed this record on September 21, 2017