- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914574
The Patellofemoral Pain Functional Performance Study (PFP-FP)
The Patellofemoral Pain Functional Performance and Arthrogenic Muscle Inhibition Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patellofemoral pain (PFP) is one of the most frequently diagnosed conditions in patients with knee complaints.
Studies investigating the therapeutic effect on PFP revealed that the majority of patients with PFP were still suffering of knee pain after 5 to 8 years, despite initially received treatment and education, indicating that the current treatments fail to prevent the chronicity of symptoms. Considering that current treatment-strategies of patients with PFP seem to be unable to avoid the development of chronic symptoms, the question arises if the underlying factors of PFP are understood sufficiently.
In contrary to the current broad body of literature on weakness, potentially underlying factors which might influence or even lead to PFP, such arthrogenic muscle inhibition (AMI) or the break phenomenon remain understudied.
Pain in PFP has been proven to be linked to quadriceps strength deficit, gluteal strength deficits, knee stability, irregularities in the quadriceps torque curve, and functional performance. Bazett et al. (2011) described that pain "is more than a symptom and might play a role in the etiology or progression of PFP". Furthermore, pain seems to play a crucial role in AMI. However, the correlation between pain and AMI in patients with PFP has not been investigated currently.
No assessment in isolation can provide a full picture of the problem. The combination of AMI, the break phenomenon with a biomechanical analysis might enable the determination of the impact of inhibition and strength on biomechanical changes. In addition, it might provide an answer to whether AMI or weakness cause biomechanical alterations, which would help to optimise treatment approaches in PFP.
The PowersTM strap strap was developed with the aim of assisting lower limb kinematics, decreasing knee varus through supporting femoral abduction and external rotation. This treatment may potentially also directly improve functional performance. As the functional performance in participants with PFP after the application of the PowersTM strap has not been investigated, this study aims to analyse if there is a direct link between the application of the PowersTM strap to functional performance and pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Greater Manchester
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Salford, Greater Manchester, United Kingdom, M66PU
- University of Salford
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for patients with PFP:
- Reproducible pain with at least two of these activities: ascending or descending stairs or ramps, squatting, kneeling, prolonged sitting, hopping/ jumping, isometric quadriceps contraction or running
- Clearly defined pain location in the peripatellar region
- Reports of pain greater than 1 month duration.
- They are able to perform squatting, running and MVC task- Participant response
- Age range: 18-45 years old
Inclusion criteria for healthy volunteers:
- Healthy and without any previous lower limb injuries
- The participant is able to perform squatting, running and MVC task
Exclusion Criteria:
- Previous history of knee surgery
- Previous history of (traumatic) patella dislocation or instability
- Previous history of ligamentous instabilities
- Previous history of traumatic, inflammatory or infectious pathology in the lower extremity
- Previous history of internal derangement or other causes
- Previous diagnosed degenerative conditions in the knee
- Exclusion if patients cannot perform running, step down, or MVC task.
- Exclusion criteria for the healthy control group are: clinical evidence of other knee injury or knee pain, and current significant injury affecting other lower extremity joints.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: healthy control
Healthy control group will attend one visit and functional performance, muscle strength and flexibility, quadriceps AMI, patellar position and posture will be measured.
No intervention will be applied.
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The powers strap aims to decrease knee varus through supporting femoral abduction and external rotation.
Participants will wear the Powers strap while performing functional tasks (running, squatting, single leg step down).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of Powers strap
Time Frame: 1 day
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The influence of the Powers strap on functional performance will be investigated by analysing hip and knee kinematics and kinetics with and without the Powers strap in participants with PFP
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1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSCR15-143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain
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Laval UniversityCompletedPatellofemoral Pain (PFPS)Canada
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Lauren EricksonAmerican College of Sports MedicineCompleted
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University of MelbourneNational Health and Medical Research Council, AustraliaCompletedKnee Pain | Patellofemoral PainAustralia
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Universidade Federal do CearáNot yet recruitingPatellofemoral Pain SyndromeBrazil
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University of Central LancashireCompletedPatellofemoral PainUnited Kingdom
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Universidade Federal do CearáCompletedPatellofemoral Pain SyndromeBrazil
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European University CyprusCompleted
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Universidade Federal do Rio Grande do NorteUnknown
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Aalborg UniversityCompletedPatellofemoral Pain SyndromeDenmark
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University of VirginiaAccelerated Care Plus; Mid-Atlantic Athletic Trainers' AssociationCompletedPatellofemoral Pain SyndromeUnited States
Clinical Trials on PowersTM strap
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Thomas Jefferson UniversityEnrolling by invitationBurnout | Wellness | Remote MonitoringUnited States
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Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Milton S. Hershey Medical CenterCompletedRemote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility StudyInflammatory Bowel DiseasesUnited States
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Decathlon SEEFOR, FranceRecruitingEpicondylitis | Elbow SprainFrance
-
Kai Medical, Inc.CompletedSnoring | Sleep ApneaUnited States
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Thomas Jefferson UniversityNot yet recruitingBurnout | Sleep Deprivation | Executive Function | WellnessUnited States
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University of ArizonaWHOOP Inc.Completed
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University of CincinnatiUnited States Air ForceCompletedPre-hospital VentilationUnited States
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Universidade Federal de Sao CarlosCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Not yet recruitingPatellofemoral Osteoarthritis
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Helse Stavanger HFCompleted