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A Controlled Trial on Recreational Runners With Patellofemoral Pain

Primary Purpose

Patellofemoral Pain (PFPS)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education
Exercise program
Gait retraining
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain (PFPS)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Muscle recruitment

Reduction of knee loading

Arm Description

Education will be given on how to modify running training to encourage improvement of symptoms.

Subjects will receive an additional exercise program targeting non task-specific strengthening and motor control exercises of the lower limb.

Subjects will receive additional personalized advice on how to modify running gait in order to reduce mechanical loads at the knee (gait retraining).

Outcomes

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)
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)
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)
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
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
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
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
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.

Full Information

First Posted
December 3, 2014
Last Updated
September 7, 2016
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02352909
Brief Title
A Controlled Trial on Recreational Runners With Patellofemoral Pain
Official Title
A Randomised Controlled Trial on Recreational Runners With Patellofemoral Pain: Effects of Rehabilitation Approaches Based on Specific Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain (PFPS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Education will be given on how to modify running training to encourage improvement of symptoms.
Arm Title
Muscle recruitment
Arm Type
Experimental
Arm Description
Subjects will receive an additional exercise program targeting non task-specific strengthening and motor control exercises of the lower limb.
Arm Title
Reduction of knee loading
Arm Type
Experimental
Arm Description
Subjects will receive additional personalized advice on how to modify running gait in order to reduce mechanical loads at the knee (gait retraining).
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
A home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks.
Intervention Type
Other
Intervention Name(s)
Gait retraining
Intervention Description
Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).
Primary Outcome Measure Information:
Title
Changes in symptoms and function using a self-reported questionnaire, the Activities of Daily Living Scale of the Knee Outcome Survey (KOS-ADLS)
Description
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
Secondary Outcome Measure Information:
Title
Changes in pain scores using Visual analog scales (VAS)
Description
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
Title
Global rating of change (GRC)
Description
Self-reported outcome used to monitor perception of improvement or worsening of the condition following the intervention.
Time Frame
After the intervention (8 weeks)
Title
Changes in the vertical loading rate of ground reaction forces during treadmill running
Description
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)
Title
Changes in ankle, knee, hip and pelvis kinematics during the stance phase of running
Description
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)
Title
Changes in patellofemoral joint load during the stance phase of running
Description
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)
Title
Changes in lower limb muscle strength
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1M 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28476901
Citation
Esculier JF, Bouyer LJ, Dubois B, Fremont P, Moore L, McFadyen B, Roy JS. Is combining gait retraining or an exercise programme with education better than education alone in treating runners with patellofemoral pain?A randomised clinical trial. Br J Sports Med. 2018 May;52(10):659-666. doi: 10.1136/bjsports-2016-096988. Epub 2017 May 5.
Results Reference
derived
PubMed Identifier
26738470
Citation
Esculier JF, Bouyer LJ, Dubois B, Fremont P, Moore L, Roy JS. Effects of rehabilitation approaches for runners with patellofemoral pain: protocol of a randomised clinical trial addressing specific underlying mechanisms. BMC Musculoskelet Disord. 2016 Jan 6;17:5. doi: 10.1186/s12891-015-0859-9.
Results Reference
derived

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A Controlled Trial on Recreational Runners With Patellofemoral Pain

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