Clinical trial NCT02352909: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain (PFPS)
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in symptoms and function using a self-reported questionnaire, the Activities of Daily Living Scale of the Knee Outcome Survey (KOS-ADLS)
timeFrame: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
Secondary outcomes:
measure: Changes in pain scores using Visual analog scales (VAS)
timeFrame: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
measure: Global rating of change (GRC)
timeFrame: After the intervention (8 weeks)
measure: Changes in the vertical loading rate of ground reaction forces during treadmill running
timeFrame: Baseline and after the intervention (8 weeks)
measure: Changes in ankle, knee, hip and pelvis kinematics during the stance phase of running
timeFrame: Baseline and after the intervention (8 weeks)
measure: Changes in patellofemoral joint load during the stance phase of running
timeFrame: Baseline and after the intervention (8 weeks)
measure: Changes in lower limb muscle strength
timeFrame: Baseline and after the intervention (8 weeks)
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Centre for Interdisciplinary Research in Rehabilitation and Social Integration
state: Quebec
Study officials:
References:
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.
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.