Patellofemoral Pain (PFPS) Clinical Trial
Official title:
A Randomised Controlled Trial on Recreational Runners With Patellofemoral Pain: Effects of Rehabilitation Approaches Based on Specific Underlying Mechanisms
| Verified date | September 2016 |
| Source | Laval University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre for Interdisciplinary Research in Rehabilitation and Social Integration | Quebec City | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Laval University |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. | After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program | No |
| Secondary | Global rating of change (GRC) | Self-reported outcome used to monitor perception of improvement or worsening of the condition following the intervention. | After the intervention (8 weeks) | No |
| Secondary | 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. | Baseline and after the intervention (8 weeks) | No |
| Secondary | 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. | Baseline and after the intervention (8 weeks) | No |
| Secondary | 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. | Baseline and after the intervention (8 weeks) | No |
| Secondary | 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. | Baseline and after the intervention (8 weeks) | No |