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Strength or Power Training for Patellofemoral Pain (STRIPE)

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ClinicalTrials.gov Identifier: NCT05403944
Recruitment Status : Recruiting
First Posted : June 3, 2022
Last Update Posted : October 14, 2022
Sponsor:
Collaborators:
University of Central Florida
University of Toledo
Information provided by (Responsible Party):
Neal Glaviano, University of Connecticut

Brief Summary:
The objective of this study is to compare a novel 6-week strength training rehabilitation incorporating power exercises (STRIPE) program to a standard of care (SOC) program on short-term and long-term pain, subjective function, patellofemoral pain recurrence rates, and secondary outcomes (hip abduction and extension rate of torque development and single-leg squat kinematics). We hypothesize that participants with patellofemoral pain who complete the STRIPE program will have 1) decreased pain, 2) improved subjective function, 3) reduced patellofemoral pain recurrence rates, 4a) improved hip abduction/extension rate of torque development, and 4b) decreased hip adduction and pelvic drop during a single leg squat compared to participants who complete a SOC rehabilitation program.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Behavioral: Standard of Care Rehabilitation (SOC) Behavioral: Strength Training Rehabilitation Incorporating Power Exercises (STRIPE) Not Applicable

Detailed Description:
The proposed study will compare strength-based exercises, which is the standard of care (SOC), that target the hip abductors, hip extensors, lumbo-pelvic, and quadriceps muscles, to a strength training program that utilized power-based exercises (Strength Training Rehabilitation Incorporating Power Exercises [STRIPE]). Individuals with patellofemoral pain, both within the military and general population, present with long-term pain, decreased subjective function, and high recurrence rates. Our primary outcomes are to determine intervention success with self-reported knee pain, measured by the visual analog scale, subjective function, measured by the anterior knee pain scale, and recurrence rates. Recent evidence suggests that two in every three individuals with patellofemoral pain report symptoms up to two years after seeking care, therefore we will assess patellofemoral pain recurrence rates for two years. Additionally, the proposed interventions target gluteal muscle function, supporting our selection of secondary outcome variables. We will assess rate of torque development, as power-based exercises are recommended to improve muscle capacity, of both the targeted gluteus medius and gluteus maximus. We will also assess frontal plane kinematics, as the gluteal muscles are responsible for controlling pelvic and hip motion during functional tasks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Clinical Outcomes for Patients With Patellofemoral Pain Using Strength Training Rehabilitation Incorporating Power Exercises
Actual Study Start Date : October 13, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.
Behavioral: Standard of Care Rehabilitation (SOC)
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.

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.
Behavioral: Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
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.




Primary Outcome Measures :
  1. Change in knee pain. [ Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention. ]
    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.

  2. 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.


  3. Patellofemoral pain recurrence [ Time Frame: 6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention ]
    The number of patients who report symptoms of patellofemoral pain

  4. Change in hip rate of torque development [ Time Frame: Immediately after the intervention. ]
    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.

  5. 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. ]
    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.

  6. 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. ]
    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.


Secondary Outcome Measures :
  1. Change in psychological factors [ Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention. ]
    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.

  2. Change in cognitive factors [ Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention. ]
    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.

  3. Change in coping strategy [ Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention. ]
    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.

  4. Change in physical activity [ Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention. ]
    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.

  5. Change in self-reported knee function [ Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention. ]
    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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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05403944


Contacts
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Contact: Neal Glaviano, PhD 8604866712 neal.glaviano@uconn.edu
Contact: Lauren C Mangum, PhD 4078232795 lauren.mangum@ucf.edu

Locations
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United States, Connecticut
University of Connecticut Recruiting
Storrs, Connecticut, United States, 06269
Contact: Neal R Glaviano, PhD, ATC    860-486-6712    neal.glaviano@uconn.edu   
United States, Florida
University of Central Florida Recruiting
Orlando, Florida, United States, 32816
Contact: L. Colby Mangum, PhD, ATC    407-823-2795    lauren.mangum@ucf.edu   
United States, Ohio
University of Toledo Recruiting
Toledo, Ohio, United States, 43606
Contact: David M. Bazett-Jones, PhD, ATC    419-530-4241    david.bazettjones@utoledo.edu   
Sponsors and Collaborators
University of Connecticut
University of Central Florida
University of Toledo
Investigators
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Principal Investigator: Neal Glaviano, PhD University of Connecticut
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Responsible Party: Neal Glaviano, Responsible Party, University of Connecticut
ClinicalTrials.gov Identifier: NCT05403944    
Other Study ID Numbers: HR22-0038
OR210126 ( Other Grant/Funding Number: Department of Defense )
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data will be available on request after manuscript has been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases