Patellofemoral Pain (PFPS)NCT02352909
A Controlled Trial on Recreational Runners With Patellofemoral Pain
A study testing Education, Exercise program and Gait retraining in people with Patellofemoral Pain (PFPS), run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain (PFPS)
- What is being tested?
- Education, Exercise program and Gait retraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Québec, Quebec, G1M 2S8
About this study
Official title: A Randomised Controlled Trial on Recreational Runners With Patellofemoral Pain: Effects of Rehabilitation Approaches Based on Specific Underlying Mechanisms
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.
Read the 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.
- Conditions
- Patellofemoral Pain (PFPS)
- Being tested
- Education, Exercise program, Gait retraining
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Gait retrainingOther
Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Education will be given on how to modify running training to encourage improvement of symptoms. Receives: 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. Receives: Other: Education; Other: 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). Receives: Other: Education; Other: Gait retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: After 4 weeks and 8 weeks of rehabilitation; 3 months after the end of the rehabilitation program
Global rating of change (GRC)
Self-reported outcome used to monitor perception of improvement or worsening of the condition following the intervention.
Measured: After the intervention (8 weeks)
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.
Measured: Baseline and after the intervention (8 weeks)
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.
Measured: Baseline and after the intervention (8 weeks)
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.
Measured: Baseline and after the intervention (8 weeks)
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.
Measured: Baseline and after the intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain (PFPS)Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352909
- Sponsor's protocol ID
- 2014-15-1 (OPPQ-REPAR)
- Other IDs
- PFC-2014
- Status last verified
- Sep 2016
- First submitted
- 3 Dec 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28476901Esculier 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.
PubMed 26738470
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on Recreational Runners With Patellofemoral Pain: Effects of Rehabilitation Approaches Based on Specific Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT02352909
- Acronym / sponsor ID
- 2014-15-1 (OPPQ-REPAR)
- Conditions
- Patellofemoral Pain (PFPS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: EducationEducation will be given on how to modify running training to encourage improvement of symptoms. |
| Muscle recruitment | Experimental | Other: Education, Other: Exercise programSubjects will receive an additional exercise program targeting non task-specific strengthening and motor control exercises of the lower limb. |
| Reduction of knee loading | Experimental | Other: Education, Other: Gait retrainingSubjects will receive additional personalized advice on how to modify running gait in order to reduce mechanical loads at the knee (gait retraining). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducation 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 | Control, Muscle recruitment, Reduction of knee loading |
| Exercise programA home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks. | Other | Muscle recruitment |
| Gait retrainingRunning gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern). | Other | Reduction of knee loading |
Primary outcome
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.
6 secondary outcomes
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
Global rating of change (GRC)
Time frame: After the intervention (8 weeks)
Changes in the vertical loading rate of ground reaction forces during treadmill running
Time frame: Baseline and after the intervention (8 weeks)
Changes in ankle, knee, hip and pelvis kinematics during the stance phase of running
Time frame: Baseline and after the intervention (8 weeks)
Changes in patellofemoral joint load during the stance phase of running
Time frame: Baseline and after the intervention (8 weeks)
Changes in lower limb muscle strength
Time frame: Baseline and after the intervention (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Derived from this study: PubMed 28476901Esculier 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.
- Derived from this study: PubMed 26738470Esculier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Exercise program and Gait retraining in people with Patellofemoral Pain (PFPS), run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.