- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00445224
Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome
February 25, 2017 updated by: Timothy Uhl
Comparison of Early Hip Strengthening to Early Quadriceps Strengthening in the Treatment of Females With Patellofemoral Pain
Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active people.
Despite the growing base of support for the early introduction of hip strengthening exercises into the rehabilitation of PFPS, there have been few randomized clinical trials comparing isolated hip to isolated quadriceps strengthening.
The purpose of this study is to determine how different exercises affect pain, strength, muscle activity, and function in female subjects with patellofemoral pain.
The researchers hypothesize that females diagnosed with PFPS who initially participate in a hip strengthening program will report a greater perceived level of function, greater strength, less pain, and improved neuromuscular activity than those who participate in a progressive quadriceps strengthening intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods: Thirty-three females with PFPS will perform either initial hip strengthening (hip group) or initial quadriceps strengthening (quad group) for 4 weeks, prior to 4 weeks of a similar program of functional weight-bearing exercises.
Self-reported pain, function, and functional strength were measured.
Isometric strength was assessed for hip abductors, external rotators, and knee extensors.
A mixed-model analysis of variance will be used to determine group differences over time.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- anterior or retropatellar knee pain reported during at least 2 of the following activities: ascending and descending stairs, hopping and running, squatting, kneeling, and prolonged sitting
- insidious onset of symptoms not related to trauma
- pain with compression of the patella
- pain on palpation of the patellar facets
Exclusion Criteria:
- symptoms present for less than one month
- clinical evidence of other knee pathology
- history of recent knee surgery within past one year
- history of patellar dislocations or subluxations
- current significant injury affecting other lower extremity joints
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hip Progressive Resistive Exercises
Exercises targeting hip musculature such as hip abduction and hip external rotation that was progressed by increased resistance following typical progressive resistive exercise approach.
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Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision.
Exercises focus on strengthening hip abduction ad external rotation musculature.
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Active Comparator: Quad Progressive Resistive Exercises
Exercises targeting quadriceps musculature such as quadriceps isometric setting, terminal knee extensions, and straight leg raises that was progressed by increased resistance following typical progressive resistive exercise approach..
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Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision.
Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)
Time Frame: weekly
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0 to 10 cm line with 0 representing no pain and 10 representing severe pain
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weekly
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Subjective Function by Lower Extremity Functional Scale Report Form
Time Frame: Baseline, Mid-Intervention, and Post-Intervention
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Baseline, Mid-Intervention, and Post-Intervention
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Visual Analog Pain Scale
Time Frame: 8 week
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Visual analog pain scale at end of intervention.
0 to 10 cm line with 0 representing no pain and 10 representing severe pain
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8 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength by Isometric Dynamometer
Time Frame: Baseline, Mid, and Post-Intervention
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Baseline, Mid, and Post-Intervention
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Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent
Time Frame: Baseline, Mid and Post-Intervention
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Baseline, Mid and Post-Intervention
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Objective Function by Step-down Task for 30 Seconds
Time Frame: Baseline, Mid, and Post-Intervention
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Baseline, Mid, and Post-Intervention
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Hip Abduction Strength
Time Frame: 8 week
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Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer
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8 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Timothy Uhl, PhD, ATC, PT, University of Kentucky
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
February 25, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0138-F2L
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
willing to share strength and patient reported outcome data at pre, mid, and post testing time points.
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
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Lauren EricksonAmerican College of Sports MedicineCompleted
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Laval UniversityCompletedPatellofemoral Pain (PFPS)Canada
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Nationwide Children's HospitalCompletedPatellofemoral Pain Syndrome | Knee Pain Chronic | Anterior Knee Pain Syndrome | Patellofemoral SyndromeUnited States
-
Istanbul Medipol University HospitalCompletedPatellofemoral Pain Syndrome | Patellofemoral Pain | Anterior Knee Pain Syndrome | Patellofemoral Syndrome | Kinesiotape | Orthotic DevicesTurkey
-
University of MelbourneNational Health and Medical Research Council, AustraliaCompletedKnee Pain | Patellofemoral PainAustralia
-
Universidade Federal do CearáNot yet recruitingPatellofemoral Pain SyndromeBrazil
-
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
Clinical Trials on Hip Progressive Resistive Exercise
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Acibadem UniversityRecruiting
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Biruni UniversityIstanbul UniversityCompleted
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Cairo UniversityCompletedAcute Myeloid Leukemia in RemissionEgypt
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Texas Woman's UniversityCompletedShoulder Impingement SyndromeUnited States
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Catholic Home CareNew York Institute of TechnologyTerminated
-
Vejle HospitalOdense University Hospital; Aarhus University Hospital; Naestved Hospital; Region... and other collaboratorsActive, not recruitingHip OsteoarthritisDenmark
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Istanbul UniversityCompletedMyofascial Pain Syndrome of NeckTurkey
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedCardiovascular Diseases | Resistance Training | Muscular Strength
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Universidade Federal do CearáCompletedOsteoarthritis, KneeBrazil
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Yeditepe UniversityCompleted