NCT02352909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

December 3, 2014

Last Update Submit

September 7, 2016

Conditions

Patellofemoral Pain (PFPS)

Outcome Measures

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)

    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 Outcomes (6)

  • Changes in pain scores using Visual analog scales (VAS)

    After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program

  • Global rating of change (GRC)

    After the intervention (8 weeks)

  • Changes in the vertical loading rate of ground reaction forces during treadmill running

    Baseline and after the intervention (8 weeks)

  • Changes in ankle, knee, hip and pelvis kinematics during the stance phase of running

    Baseline and after the intervention (8 weeks)

  • Changes in patellofemoral joint load during the stance phase of running

    Baseline and after the intervention (8 weeks)

  • +1 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Other: Education

Muscle recruitment

EXPERIMENTAL

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

Other: EducationOther: Exercise program

Reduction of knee loading

EXPERIMENTAL

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

Other: EducationOther: Gait retraining

Interventions

EducationOTHER

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.

ControlMuscle recruitmentReduction of knee loading
Exercise programOTHER

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

Muscle recruitment
Gait retrainingOTHER

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

Reduction of knee loading

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 28476901DERIVED

  • 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.

    PMID: 26738470DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Educational StatusResistance Training

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

February 2, 2015

Study Start

July 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

CA(1)