Strength or Power Training for Patellofemoral Pain (STRIPE)
Optimizing Clinical Outcomes for Patients With Patellofemoral Pain Using Strength Training Rehabilitation Incorporating Power Exercises
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Neal Glaviano, PhD
- Phone Number: 8604866712
- Email: neal.glaviano@uconn.edu
Study Locations
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Connecticut
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Storrs, Connecticut, United States, 06269
- University of Connecticut
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Florida
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Orlando, Florida, United States, 32816
- University of Central Florida
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Ohio
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Toledo, Ohio, United States, 43606
- University of Toledo
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants to be between the ages of 18-40 years old.
- Insidious onset of symptoms greater than 3 months.
- Worst pain in the previous month of 3/10 with two of the following tasks: prolonged sitting, jumping, squatting, kneeling, running, and stair ambulation.
Exclusion Criteria:
- Other forms of anterior knee pain (Osgood-Schlatter, tendon pain, bursitis, etc.).
- History of lower extremity surgery.
- History of patella subluxation, meniscal injury or ligamentous instability.
- History of referred pain from the lumbar spine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: Standard of Care (SOC)
The SOC rehabilitation group will complete three strength sessions a week.
All participants will be provided an educational pamphlet and exercises will be divided into four components - hip abductors, hip extensors, core, and quadriceps muscles.
The load magnitude for exercises will be between 60-70% of their 1 repetition max (1RM), with 3 sets of 12 repetitions and a 2-3-minute rest between sets.
Time under tension will be prescribed as slow to moderate, with a 2-second concentric phase and 2-second eccentric phase for each exercise.
Hip abductor, hip extensor, and core exercises will be initiated during week 1 and continued for the 6-week intervention, while quadriceps focused exercises will be introduced in weeks 3-6.
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6 weeks of standard of care rehabilitation will be given designed to target the core, hip, and quadriceps muscles.
Each participant will be expected to complete 3 supervised telehealth sessions per week.
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Experimental: Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
Those in the STRIPE group will complete two power and one strength training sessions a week.
All participants will be provided an educational pamphlet and exercises will be divided into four components - hip abductors, hip extensors, core, and quadriceps muscles.
The load magnitude will be greater than 60% of the 1RM, with the goal of continually loading against heavy resistance.
Participants will complete 4 sets of 6 repetitions, with 3-5 minutes of rest between sets.
Time under tension will be prescribed as <1 second for the concentric phase and 1 second for the eccentric phase of the exercise.
The strength training sessions will adhere to same parameters as the SOC.
Hip abductor, hip extensor, and core exercises will be initiated during week 1 and continued for the 6-week intervention, while quadriceps focused exercises will be introduced in weeks 3-6.
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6 weeks of STRIPE rehabilitation will be given designed to target the core, hip, and quadriceps muscles.
Each participant will be expected to complete 3 supervised telehealth sessions per week.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knee pain.
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Data are presented as knee pain, assessed on the visual analog scale in centimeters, resulting in a score of 0-10, with 0 representing no pain and 10 being worst pain imaginable.
Group means and standard deviations will be reported.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Change in self-reported knee function.
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
|
Data are presented as self-reported knee function, assessed by the anterior knee pain scale. The scale ranged between 0-100, with 0 indicating complete disability and 100 indicating no disability. Group means and standard deviations will be reported. |
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Patellofemoral pain recurrence
Time Frame: 6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention
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The number of patients who report symptoms of patellofemoral pain
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6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention
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Change in hip rate of torque development
Time Frame: Immediately after the intervention.
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Hip abduction and extension rate of torque development will be assessed with a handheld dynamometer.
Data are reported as linear, with higher scores representing a faster ability to develop hip muscle force.
Group means and standard deviations will be reported.
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Immediately after the intervention.
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Change in hip adduction during a single leg squat
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Data are presented as a degree, with a higher number representing a higher amount of hip adduction.
Group means and standard deviations will be reported.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Change in pelvic drop during a single leg squat
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Data are presented as a degree, with a higher number representing a higher amount of pelvic drop.
Group means and standard deviations will be reported.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in psychological factors
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Psychological factors will be measures with the PROMIS-10, a 10-item general self-reported questionnaire that assess general domains related to physical, mental, and social health, in addition to perceived quality of life.
PROMIS-10 scores are standardized to the general population using a "T-Score", which is a score of 50 points and a standard deviation of 10-points.
Higher scores on the PROMIS-10 indicate a healthier patient.
Group means and standard deviations will be reported.
|
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Change in cognitive factors
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Cognitive factors will be assessed with the Fear-Avoidance Belief Questionnaire (FABQ), a dimension specific questionnaire.
The FABQ contains two subscales - physical activity section that includes six-items, while the work section includes ten-items.
The physical activity subscale score range between 0-24 and the work subscale is scored between 0-42.
Higher scores identifying greater fear avoidance beliefs for both physical activity and work subscales.
Group means and standard deviations will be reported.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Change in coping strategy
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Coping strategies will be assessed with the Pain Self-Efficacy Questionnaire (PSEQ), a dimension specific questionnaire.
The PSEQ is a ten-item, dimension specific questionnaire that assesses how confident participants are with performing activities while experiencing pain.
Each item is rated on a scale ranging from 0 ("not at all confident") to 6 ("completely confident").
The PSEQ score ranges between 0-60, with a higher score representing higher confidence to function with pain.
Group means and standard deviations will be reported.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Change in physical activity
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Physical activity will be quantified with the International Physical Activity Questionnaire - Short Form (IPAQ-SF), a dimension specific questionnaire.
The IPAQ-SF is a 4-item short form that measures physical activity from the previous 7-days.
Questions include the number of days per week the participant engaged in vigorous activities, moderate activities, walking, and sitting, with a follow-up question for each asking for duration of time for each task.
Group means and standard deviations will be reported.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Change in self-reported knee function
Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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The Knee Injury and Osteoarthritis Outcome Scale (KOOS) and the PFP subscale (KOOS-PF) will provide region and disease specific data throughout the study.
The KOOS measures five separate dimensions; pain, symptoms, activities of daily living function, sports and recreational function, and quality of life.
Each of the five domains are scored on a scale between 0-100, with lower scores representing greater impairments in self-reported function.
The KOOS-PF subscale is an 11-item region specific questionnaire, ranging from 0-100, with greater scores also reflecting greater function.
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Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Neal Glaviano, PhD, University of Connecticut
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HR22-0038
- OR210126 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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