- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663595
Treatment Effects on Neuromuscular Properties on Young Women Symptomatic for Patellofemoral Pain Syndrome
Effects of Two Treatment Models on Neuromuscular Properties of Young Women Symptomatic for Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
- Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patellofemoral pain syndrome group:
Inclusion Criteria:
A physiotherapist evaluated PFP participants' eligibility based on the following criteria: (1) presence of peripatelar or retropatelar pain in at least two functional tasks (squatting, running, kneeling, jumping, climbing or descending stairs, sitting for a long time, sitting with knees flexed), (2) ongoing patellar pain for at least 3 months, (3) PFP with a minimum of 3 out of 10 points in the numeric rating scale for knee pain (0 = "no pain", 10 = "intolerable pain"), (4) beginning of PFP symptoms not related to trauma and (5) not participating in any PFP treatment in the last 12 months
Exclusion Criteria:
- Participants were excluded if they presented signs or symptoms of (1) meniscal or other intra-articular pathologies; (2) signs of patellar apprehension; (3) history of hip, knee, or ankle joint injury; (4) evidence of joint effusion; and (5) history of patellofemoral joint surgery.
Healthy group (n=20): women with no history of PFP in the last 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PFPS: Model 1 (Hip and Knee)
Females symptomatic for PFPS.
This group will be submitted to the rehabilitation program with exercises focusing in proximal (hip) and local (knee) factors.
|
Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.
Other Names:
|
EXPERIMENTAL: PFPS: Model 2 (knee, foot and ankle)
Females symptomatic for PFPS This group will be submitted to the rehabilitation program with exercises focusing in distal (foot and ankle) and local (knee) factors.
|
Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.
Other Names:
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NO_INTERVENTION: Healthy group
Healthy females not submitted to intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of knee pain
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Knee pain will be measured with a Numeric Pain Rating Scale (0 to 10)
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Self-reported functionality
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Self-reported functionality will be measured by Anterior Knee Pain Scale by Kujala Questionaire (1993)
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Change in knee muscles, hip muscles, ankle muscles and foot muscles strength
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Torque is an expression of the muscular strength and was assessed by dynamometry
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Change of kinematic of pelvis, hip, knee and ankle during single leg squat
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Single leg squat will be measured with a video camera, and will be used to determine lower limb alignement
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Change of kinematic of pelvis, hip, knee and ankle during drop landing test
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
rop landing will be measured with a video camera, and will be used to determine lower limb alignement
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Change of knee muscles, hip muscles, ankle muscles and foot muscles architecture
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Muscular architecture (muscle thickness) will be assessed by ultrasonography
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Muscle activation
Time Frame: The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Muscle activation will be assessed by electromyography
|
The evaluation will be performed to baseline (pre-intervention), change from baseline to 6 weeks of intervention and change from baseline to 12 weeks of intervention.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- UFRGS - 2.809.328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Syndrome
-
Lauren EricksonAmerican College of Sports MedicineCompleted
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Nationwide Children's HospitalCompletedPatellofemoral Pain Syndrome | Knee Pain Chronic | Anterior Knee Pain Syndrome | Patellofemoral SyndromeUnited States
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Istanbul Medipol University HospitalCompletedPatellofemoral Pain Syndrome | Patellofemoral Pain | Anterior Knee Pain Syndrome | Patellofemoral Syndrome | Kinesiotape | Orthotic DevicesTurkey
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Universidade Federal do CearáCompletedPatellofemoral Pain SyndromeBrazil
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